COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S011 · decided 2008-09-26
Approval details
- PMA number
- P030039
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2008-08-29
- Decision date
- 2008-09-26
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR ADDITION OF SAFETY RELATED STATEMENTS TO THE LABELING.
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