|
Device | TECHSTAR XL 6 FR. PERCUTANEOUS VASCULAR SURGICAL DEVICES |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S020 |
Date Received | 07/23/1999 |
Decision Date | 09/16/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the manufacture and quality control of the Techstar(R) XL PVS System. |