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 | BIOGLUE SURGICAL ADHESIVE |
Generic Name | Glue, surgical, arteries |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P010003 |
Supplement Number | S015 |
Date Received | 04/30/2010 |
Decision Date | 05/12/2010 |
Product Code |
MUQ |
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 CLARIFICATION REGARDING ONE OF THE WARNINGS IN THE INSTRUCTIONS FOR USE (IFU). |
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