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 | S006 |
Date Received | 07/25/2005 |
Decision Date | 04/13/2006 |
Product Code |
MUQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR TWO MANUFACTURING SITES: 1) CENTURION STERILIZATION SERVICES, PART OF TRI-STATE HOSPITAL SUPPLY, SALISBURY, NORTH CAROLINA FOR THE STERILIZATION OF BIOGLUE EXTENDER TIPS; AND 2) COMMAND MEDICAL PRODUCTS, ORMOND BEACH, FLORIDA AS A COMPONENT ASSEMBLER. |
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