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. |
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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 | S002 |
Date Received | 06/24/1996 |
Decision Date | 08/01/1996 |
Withdrawal Date
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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 "SPECIAL PMA SUPPLEMENT - CHANGES BEING EFFECTED" AND PROVIDES FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE USE OF THE DEVICE |
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