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 | COSEAL SURGICAL SEALANT (PREMIXED) |
Generic Name | Sealant, polymerizing |
Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.W 47TH AVENUE GAINESVILLE, FL 32608 |
PMA Number | P010022 |
Supplement Number | S001 |
Date Received | 08/09/2002 |
Decision Date | 02/04/2003 |
Withdrawal Date
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03/15/2012 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) CHANGE IN PACKAGING OF THE POLYMER RESINS TO A PRE-MIXED CONFIGURATION; 2) CHANGE IN BUFFER A TO A DILUTE HYDROGEN CHLORIDE SOLUTION WITH A PH OF 2.2; 3) CHANGE IN STERILIZATION TO GAMMA RADIATION; AND 4) CHANGE TO ROOM TEMPERATURE STORAGE. |
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