COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR
FDA premarket approval P030039/S019 · decided 2015-11-24
Approval details
- PMA number
- P030039
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSEAL SURGICAL SEALANT, COSEAL REPLACEMENT APPLICATOR, COSEAL EXTENDED APPLICATOR
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2015-10-16
- Decision date
- 2015-11-24
- Days to decision
- 39 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- A CHANGE IN RESIN USED IN THE MOLDING OF SEVERAL DELIVERY SYSTEM COMPONENTS.
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