|
Device | THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S028 |
Date Received | 11/13/2000 |
Decision Date | 12/12/2000 |
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 REDUCING THE SHEATH TO GUIDE TENSILE STRENGTH ACCEPTANCE CRITERIA TO A MINIMUM OF 5 LBF. FROM 7 LBF. |