Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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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 |
Date Received | 10/26/2006 |
Decision Date | 06/03/2010 |
Withdrawal Date
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10/18/2021 |
Product Code |
NBE |
Docket Number | 10M-0285 |
Notice Date | 06/11/2010 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ETHICON OMNEX SURGICAL SEALANT. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S003 S004 S005 |
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