ETHICON OMNEX SURGICAL SEALANT
FDA premarket approval P060029/S005 · decided 2014-01-17
Approval details
- PMA number
- P060029
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ETHICON OMNEX SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- ETHICON, Inc.
- Date received
- 2013-01-08
- Decision date
- 2014-01-17
- Days to decision
- 374 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ETHICON, INC., IN CORNELIA, GEORGIA.
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