ETHICON OMNEX SURGICAL SEALANT
FDA premarket approval P060029 · decided 2010-06-03
Approval details
- PMA number
- P060029
- Trade name
- ETHICON OMNEX SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- ETHICON, Inc.
- Date received
- 2006-10-26
- Decision date
- 2010-06-03
- Days to decision
- 1316 days
- Decision code
- APWD
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Somerville, NJ
- 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.
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