|
Device | PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S037 |
Date Received | 01/14/2002 |
Decision Date | 02/13/2002 |
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 RECLASSIFICATION OF THE CLEANROOM FROM CLASS 10,000 OF THE FEDERAL STANDARD 209E TO CLASS 8 OF ISO 14644-1 USED IN THE MANUFACTURE OF THE PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS. |