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 | ACS MULTI-LINK CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S006 |
Date Received | 10/19/1998 |
Decision Date | 11/10/1998 |
Product Code |
MAF |
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 The 30-day Notice requested that FDA review a change in the manufacturing process, removing the C-flex Junction Shear Strength Test, a design verification test, from production testing of the ACS RX MULTI-LINK(TM) Coronary Stent System and the ACS RX MULTI-LINK HP(TM) Coronary Stent System. |
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