Attachment_11_-_Form_3514.pdf

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Page of Pages Supplement

CDRH PREMARKET REVIEW SUBMISSION COVER SHEET

Form Approval OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on page 5.

Form Approval O M B Number 0910-0120 Expiration Date: December 31, 2013.

See O M B Statement on page 5.

Date of Submission (If Yes, please complete Section I, Page 5) Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name Contact E-mail Address Company / Institution Name Contact Title ZIP/Postal Code State / Province Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name Contact E-mail Address Evaluation of Automatic Class III Designation (De Novo) APPLICATION CORRESPONDENT (e.g., consultant, if different from above)

FORM FDA 3514 (1/13)

PMA

PMA & HDE Supplement Establishment Registration Number (if known) Original Submission

PDP

510(k) Other Submission Humanitarian Device Exemption (HDE) Amendment Class II Exemption Petition Original Submission Additional Information Original Submission Original Submission Additional Information Original Submission Amendment No Supplement

SUBMITTER, APPLICANT OR SPONSOR

IDE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Report Amendment

TYPE OF SUBMISSION

State / Province ZIP Code Country Country Additional Information Other (describe submission):

Contact Title FDA Submission Document Number (if known) User Fee Payment ID Number 513(g) Notice of Completion Amendment to PDP Original PDP Regular (180 day) Special Panel Track (PMA Only) 30-day Supplement 30-day Notice 135-day Supplement Real-time Review Abbreviated (Complete section I, Page 5) Special Traditional Original Submission:

Modular Submission Other Amendment Report Report Amendment Premarket Report Licensing Agreement Third Party Amendment to PMA & HDE Supplement Company / Institution Name Have you used or cited Standards in your submission?

Report Yes

SECTION A

SECTION C

SECTION B

PSC Publishing Services (301) 443-6740 EF Request for Feedback Informational Meeting Study Risk Determination Pre-Submission Day 100 Meeting Agreement Meeting Determination Meeting Submision Issue Meeting Pre PMA (pronounced PM Eh for screen reader use) Meeting Other (specify):

Additional or Expanded Indications Request for Applicant Hold Withdrawal Post-approval Study Protocol Request to Remove or Add Manufacturing Site Request for Extension Request for Removal of Applicant Hold New Device Manufacturing Packaging Sterilization Other (specify below) Post-approval Study Packager Process change:

Response to FDA correspondence:

Change of Applicant Address Location change:

Sterilizer Manufacturer New Indication Request Hearing Other Reason (specify):

Adverse Reaction Device Defect Amendment Change in design, component, or specification:

Report Submission:

Annual or Periodic Color Additive Material Software / Hardware Change in Ownership Change in Correspondent Specifications Other (specify below) Labeling change:

Indications Performance Characteristics Instructions Shelf Life Trade Name Other (specify below) Other Reason (specify):

Change in Technology New Device

REASON FOR APPLICATION - PMA, PDP, OR HDE

REASON FOR SUBMISSION - 510(k)

FORM FDA 3514 (1/13)

REASON FOR APPLICATION - IDE

New Device Expansion / Extension of Study IRB Certification Addition of Institution Termination of Study Withdrawal of Application Continued Access Unanticipated Adverse Effect Compassionate Use Request Treatment IDE Notification of Emergency Use Change in:

Design / Device Informed Consent Correspondent / Applicant Manufacturer Protocol - Feasibility Protocol - Other Manufacturing Process Response to FDA Letter Concerning:

Sponsor Deemed Approved Deficient Final Report Conditional Approval Site Waiver Report Current Investigator Annual Progress Report Report submission:

Deficient Progress Report Disapproval Request Extension of Time to Respond to FDA Deficient Investigator Report Request Meeting Final Other Reason (specify):

Additional or Expanded Indications

SECTION D1

SECTION D3

SECTION D2

Trade or Proprietary or Model Name 510(k) Number Product codes of devices to which substantial equivalence is claimed Manufacturer Information on devices to which substantial equivalence is claimed (if known)

PRODUCT INFORMATION - APPLICATION TO ALL APPLICATIONS

PRODUCT CLASSIFICATION - APPLICATION TO ALL APPLICATIONS

Common or usual name or classification name Trade or Proprietary or Model Name for This Device Model Number FDA document numbers of all prior related submissions (regardless of outcome) Data Included in Submission Laboratory Testing Animal Trials Human Trials Device Class Product Code C.F.R. Section (if applicable) Classification Panel Indications (from labeling) Class I Class II Class III Unclassified Summary of, or statement concerning, safety and effectiveness information 510 (k) summary attached 510 (k) statement

ADDITIONAL INFORMATION ON 510(K) SUBMISSIONS

FORM FDA 3514 (1/13)

SECTION F

SECTION G

SECTION E

FORM FDA 3514 (1/13)

Note: Submission of the information entered in Section H does not affect the need to submit device establishment registration.

FDA Document Number (if known) Add Add Contract Manufacturer

MANUFACTURING / PACKAGING / STERILIZATION SITES RELATING TO A SUBMISSION

Contract Manufacturer Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer ZIP Code State / Province Country Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name ZIP Code State / Province Country Contact E-mail Address Contact Title Contact E-mail Address Contact Title Add Contract Manufacturer Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name ZIP Code State / Province Country Contact E-mail Address Contact Title

SECTION H

FORM FDA 3514 (1/13)

Note: Submission of this information does not affect the need to submit a 2891 or 2891a Device Establishment Registration form.

FDA Document Number (if known) Add Add Contract Manufacturer Contract Manufacturer Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer ZIP Code State / Province Country Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name ZIP Code State / Province Country Contact E-mail Address Contact Title Contact E-mail Address Contact Title Add Contract Manufacturer Repackager / Relabeler Facility Establishment Identifier (FEI) Number Original Manufacturer Contract Sterilizer Delete Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) Street Address FAX Number (including area code) City Contact Name ZIP Code State / Province Country Contact E-mail Address Contact Title SECTION H (Continued)

UTILIZATION OF STANDARDS

FORM FDA 3514 (1/13)

Standards Organization Please include any additional standards to be cited on a separate page.

The burden time for this collection of information is estimated to average 0.5 hour per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*

This section applies only to requirements of the Paperwork Reduction Act of 1995.

asterisk DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW. asterisk Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff1350 Piccard Drive, Room 400Rockville, MD 20850 An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement.

Date Standards No.

Standards Title Version Standards Organization Date Standards No.

Standards Title Version Standards Organization Standards Organization Date Standards No.

Standards Title Version Standards Organization Date Standards No.

Standards Title Version Standards Organization Date Standards No.

Standards Title Version Standards Organization Date Standards No.

Standards Title Version Date Standards No.

Standards Title Version

SECTION I

FORM FDA 3514 (1/13)

CDRH PREMARKET REVIEW SUBMISSION COVER SHEET

(v5.5) PSC Publishing Services Beth Sands; 7-1480 1/10/02 1/13

POD

for FDA If known (and not already entered), please type the F D A Document Number here. This is the 1st continuation page.