AMENDMENT 0001_QUESTIONS AND ANSWERS_FDA-SOL-1253811.pdf

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Pulsatile Pump System
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AMENDMENT 0001 - QUESTIONS AND ANSWERS

FDA-SOL-1253811

May 18, 2022

Question:

Can you please further advise to the expectation associated with the minimum characteristic: 1) M Shall include an analog voltage control of the pump? Do you require the pump to have a separate analog input connector for this characteristic or can the analog voltage wiring be integrated in the existing pump cabling?

Answer to Question:

It works if it is integrated in the pump cabling. No separate input required.

NO FURTHER QUESTIONS WILL BE CONSIDERED FOR FDA-SOL-1253811

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