Coseal Spray Set
FDA premarket approval P030039/S031 · decided 2025-08-21
Approval details
- PMA number
- P030039
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Coseal Spray Set
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2025-07-24
- Decision date
- 2025-08-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- changing the cutting of the tubing from a manual to an automated process for the COSEAL Spray Set
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