|
Device | STARCLOSE VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S007 |
Date Received | 12/12/2007 |
Decision Date | 01/11/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF A STEP TO THE MANUFACTURING PROCESS TO IMPLEMENT HEAT FORMING AT THE PUSHER BODY/ OBTRUATOR SHAFT JOINT FOR THE DEVICE. |