Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | STARR EDWARDS SILASTIC BALL VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870038 |
Supplement Number | S004 |
Date Received | 12/15/2000 |
Decision Date | 01/05/2001 |
Withdrawal Date
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01/28/2022 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE PACKAGING DESIGN FROM A TWO-PIECE MOLDED POLYSULFONE CANISTER TO A THERMOFORMED POLYCARBONATE TRAY WITH INSERT AND TYVEK LID. |
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