Coseal Surgical Sealant
FDA premarket approval P030039/S021 · decided 2018-02-07
Approval details
- PMA number
- P030039
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Coseal Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2018-01-25
- Decision date
- 2018-02-07
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval to add endotoxin Limulus Amebocyte Lysate (LAL) testing for stand-alone Replacement and Extended Applicators.
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