Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
FDA premarket approval P030039/S023 · decided 2018-07-26
Approval details
- PMA number
- P030039
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2018-05-03
- Decision date
- 2018-07-26
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval for implementing a new sterilization chamber and cycle for the Coseal Spray Set.
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