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Device | PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S061 |
Date Received | 10/23/2007 |
Decision Date | 11/21/2007 |
Product Code |
MGB |
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 TO THE STERILIZATION LOAD SIZE FROM 6 TO 13 PALLETS AND A CHANGE TO THE BIOLOGICAL INDICATORS (BIS), WHICH NOW CONSIST OF AN INOCULATED PEEBAX TUBE IN AN ENVELOPE. |