Coseal Surgical Sealant
FDA premarket approval P030039/S020 · decided 2018-03-22
Approval details
- PMA number
- P030039
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Coseal Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2017-12-04
- Decision date
- 2018-03-22
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval for a manufacturing site located at Baxter S.A., Boulevard Rene Branquart 80 7860 Lessines, Belgium for final release testing and product release functions of the Coseal Surgical Sealant Spray Set (Coseal Spray Set).
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