COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S014 · decided 2009-12-18
Approval details
- PMA number
- P030039
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2009-09-04
- Decision date
- 2009-12-18
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR A CHANGE IN THE MATERIALS USED TO MAKE THE SYRINGE THAT HOLDS THE POLYETHYLENE GLYCOL (PIG) POLYMERS.
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