Coseal Surgical Sealant
FDA premarket approval P030039/S026 · decided 2021-07-15
Approval details
- PMA number
- P030039
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Coseal Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2021-04-21
- Decision date
- 2021-07-15
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval for implementation of the BD Sterifill Advanced Syringe as a replacement for the previously used BD Sterifill.
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