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 | S007 |
Date Received | 10/31/2005 |
Decision Date | 12/08/2005 |
Product Code |
MUQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A 10 ML SYRINGE VOLUME; A SOFTER POLYMER IN THE PISTON OF THE SYRINGE; AN ALTERNATE SUPPLIER FOR THE POLYETHYLENE FOR THE CAP PLUG OF THE ENTIRE DELIVERY SYSTEM PRODUCT LINE; AND ADDITION OF A 10 PACK OF POUCHED (4/POUCH) STANDARD SYRING TIPS. |
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