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 | S001 |
Date Received | 05/03/2002 |
Decision Date | 07/29/2002 |
Product Code |
MUQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR 1) ADDING AN ADDITIONAL VENDOR, DOMNICK HUNTER, PLC, FOR THE 0.2 UM-FILTER TO FILTER BULK COMPONENT SOLUTIONS, AND 2) ADDING A SOLUTION MIXING SYSTEM FOR THE BOVINE SERUM ALBUMIN BULK SOLUTION FOR BAGS UP TO 20L IN CAPACITY. |
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