ETHICON OMNEX SURGICAL SEALANT
FDA premarket approval P060029/S003 · decided 2012-02-03
Approval details
- PMA number
- P060029
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETHICON OMNEX SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- ETHICON, Inc.
- Date received
- 2011-06-29
- Decision date
- 2012-02-03
- Days to decision
- 219 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 LLC., IN SAN LORENZO, PUERTO RICO.
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