Coseal Surgical Sealant
FDA premarket approval P030039/S025 · decided 2020-07-16
Approval details
- PMA number
- P030039
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Coseal Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2020-04-17
- Decision date
- 2020-07-16
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval for a shelf-life extension from 6 months to 12 months.
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