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 | ETHICON OMNEX SURGICAL SEALANT |
Generic Name | Sealant, polymerizing |
Applicant | ETHICON, INC. ROUTE 22 WEST SOMERVILLE, NJ 08876 |
PMA Number | P060029 |
Supplement Number | S004 |
Date Received | 05/29/2012 |
Decision Date | 06/29/2012 |
Withdrawal Date
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10/18/2021 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TRANSFER OF THE INCOMING INSPECTION PROCESS FROM ETHICON, INC. IN RALEIGH, NORTH CAROLINA TO ETHICON LLC IN SAN LORENZO, PUERTO RICO. |
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