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 | TECHSTAR AND PROSTAR PERCUTANEOUS VASCULAR SURGICAL SYSTEMS |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S013 |
Date Received | 11/12/1998 |
Decision Date | 12/07/1998 |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization facility located at Griffith Micro Science, Inc. 4900 South Gifford Ave., Los Angeles, CA 90058. |
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