Coseal Surgical Sealant
FDA premarket approval P030039/S030 · decided 2025-04-11
Approval details
- PMA number
- P030039
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Coseal Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2025-03-12
- Decision date
- 2025-04-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- performing the endotoxin testing in-house at the Baxter Hayward facility for Coseal Surgical Sealant
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