ETHICON OMNEX SURGICAL SEALANT
FDA premarket approval P060029/S004 · decided 2012-06-29
Approval details
- PMA number
- P060029
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETHICON OMNEX SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- ETHICON, Inc.
- Date received
- 2012-05-29
- Decision date
- 2012-06-29
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Somerville, NJ
- 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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