Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VASOSEAL (TM) |
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 | S004 |
Date Received | 10/22/1996 |
Decision Date | 12/02/1996 |
Withdrawal Date
|
12/06/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGES TO THE INDICATIONS FOR USE TO INCLUDE USE OF VASOSEAL(R) FOLLOWING NON-CORONARY ANGIOGRAPHY AND NON-CORONARY BALLOON ANGIOPLASTY PROCEDURES |
|
|