|
Device | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S004 |
Date Received | 05/28/1997 |
Decision Date | 07/10/1997 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changing the test methodology for measuring molecualr weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process. |