36C25725Q0573 Watchman Pro.docx

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6515--WATCHMAN FLX PRO
Solicitation number
36C25725Q0573
Issued by

About this file

This is a Sources Sought Notice for the procurement of the Watchman FLX PRO medical device for the North Texas VA Healthcare System in Dallas, Texas. The Department of Veterans Affairs is conducting market research to determine potential sources and procurement strategy for a future solicitation, with specific interest in Service-Disabled Veteran-Owned Small Businesses (SDVOSB), Veteran-Owned Small Businesses (VOSB), or other small business manufacturers and authorized distributors of the device.

The Watchman FLX PRO is a 40mm surgical implant designed for percutaneous, transcatheter closure of the left atrial appendage, featuring HEMOCOAT Technology, radiopaque markers, and intended to reduce thromboembolism risk. Interested vendors must respond by 11:00 AM Central Time on May 22, 2025, and provide detailed information including business name, address, contact details, SAM UID number, NAICS code, business size, business type, proof of OEM authorization, and estimated market research pricing. The VA is particularly interested in items manufactured in the United States and will use the responses to determine whether the future solicitation will be set aside for small businesses.

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Sources Sought Notice Sources Sought Notice

SUBJECT*
WATCHMAN FLX PRO

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
76504
SOLICITATION NUMBER*
36C25725Q0573
RESPONSE DATE/TIME/ZONE
05-22-2025 11:00 CENTRAL TIME, CHICAGO, USA
ARCHIVE
5 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N

SET-ASIDE

PRODUCT SERVICE CODE*
6515
NAICS CODE*
339114

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs

5441 Babcock Rd. Ste. 302 San Antonio, TX 78240

POINT OF CONTACT*

Contract Specialist Michelle Cunningham michelle.cunningham@va.gov

(254) 408-1652

PLACE OF PERFORMANCE

ADDRESS
North Texas VA Healthcare System

4500 South Lancaster Road

Dallas Texas

POSTAL CODE
75216
COUNTRY
USA

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov/
URL DESCRIPTION
VA
AGENCY CONTACT’S EMAIL ADDRESS
michelle.cunningham@va.gov
EMAIL DESCRIPTION
POC

DESCRIPTION

This market research notice is being conducted by Network Contracting Office (NCO) 17 VHA Regional Procurement Office-West (RPOW) 124 E. 5441 Babcock Road STE 302, San Antonio, Texas 78240 for the procurement of the Watchman FLX PRO.

Background and Requirement: Contractor shall provide supplies and services for the North Texas (Dallas) Healthcare System, located at 4500 S. Lancaster Rd, Dallas, Texas 75216.

1. WATCHMAN FLX PRO shall be in accordance with the original equipment manufacturer (OEM) specifications.

· Kind of material: The WATCHMAN FLX Pro Device is designed with three first-ever features: new HEMOCOAT Technology designed to improve the healing process, radiopaque markers for precise device placement, and a new 40mm size for larger appendages.

· Dimensions, size, capacity: 40MM

· Principles of operation: watchman FLX Pro is intended for percutaneous, transcatheter closure of the left atrial appendage.

· Restrictive environmental conditions: AMBIENT STORAGE (15-25 degree Celsius)

· Intended use: This equipment can reduce the risk of thromboembolism

· End item application: Surgical Implant

· Other pertinent information that describes the item, material or service required: IMPLANT REPLACEMENT

Where are the items manufactured at? Provide the City and State: Include this information in your response.

1. This equipment for proposed is the WATCHMAN FLX PRO.

2. SPECIFIC INSTRUMENT REQUIRED: North Texas (Dallas) Healthcare System, located at 4500 S. Lancaster Rd, Dallas, Texas 75216.

3. If this is an item your business can provide, please respond to this Sources Sought Notice by 11:00 AM Central Time on Thursday, 22 May 2025.

4. The intent of this notice is to establish sources to define the procurement strategy (e.g. set-aside, sole source, unrestricted) for a solicitation that VA intends to post soon. Interested contractors are requested to respond in accordance with the following:

a. where the item is manufactured; the VA is interested in procuring items manufactured in the United States.

b. If you have an existing GSA or VA, Federal Supply Schedule contract, include the contract details in your response.

c. Please note that VA is particularly interested in determining the availability of Service Disable Veteran Owned Small Business/Veteran Owned Small Business or other Small Business manufacturers or authorized distributors that can provide this item.

d. Respond to this notice if you can provide these products listed in the table in the background and requirement section above. In the response, please cite your business size status.

e. DISTRIBUTORS: You must provide proof that you are an authorized distributor. VA does not accept gray market items.

f. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g. if CO determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside).

5. Responses should include:

(1) Business Name

(2) Business Address

(3) Point of Contact

- Name

- Phone Number

- E-mail Address

(4) SAM UID Number

(5) NAICS code

(6) Business Size: SMALL or LARGE

(7) Type of Business: SERVICE-DISABLED VETERAN OWNED (SDVOSB), VETERAN OWNED(VOSB), 8A, HUBZone, WOMAN-OWNED (WOSB), etc.

(8) Letter stating OEM authorized dealer, authorized distributor, or authorized reseller for the proposed equipment and/or services if applicable

(9) GSA/FSS Contract Number if applicable

All businesses eligible to provide this item are encouraged to reply as this information may be used to determine potential set-asides for the above-noted requirement.

6. Send responses to Michelle Cunningham at michelle.cunningham@va.gov.

DISCLAIMER: THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTES. However, Contractors may submit a capability statement, proposal, or quotation which shall be considered by the contracting officer whether to continue with the sole source procurement or to provide for competition. Due to technical issues, please allow additional time if you’re using electronic means.

Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government.

*= Required Field
Sources Sought Notice

Sources Sought Notice

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