|
Device | VASOSEAL VHD & ES DEVICES |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P920004 |
Supplement Number | S016 |
Date Received | 02/05/2002 |
Decision Date | 03/07/2002 |
Withdrawal Date
|
12/06/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE INSTRUCTIONS FOR USE. SPECIFICALLY, TO REMOVE THE OCCLUSIVE PRESSURE WHILE MAINTAINING ADHESIVE (DEVICE) PLUNGER PRESSURE AND POSITIONS AFTER THE FIRST COLLAGEN CARTRIDGE HAS BEEN DEPLOYED. |