ETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING
FDA premarket approval P060029/S001 · decided 2010-09-07
Approval details
- PMA number
- P060029
- Supplement
- S001
- Supplement type
- Real-Time Process
- Trade name
- ETHICON OMNEX SURGICAL SEALANT APPLICATOR AND PACKAGING
- Generic name
- Sealant, polymerizing
- Applicant
- ETHICON, Inc.
- Date received
- 2010-07-09
- Decision date
- 2010-09-07
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Somerville, NJ
- Statement
- APPROVAL FOR CHANGES TO THE APPLICATOR AND PACKAGING.
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