|
Device | PERCLOSE PROGLIDE AND PERCLOSE AT 6F 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 | S085 |
Date Received | 12/31/2013 |
Decision Date | 01/29/2014 |
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 JOINT TENSILE TESTING PROCESS. |