Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
FDA premarket approval P030039/S024 · decided 2020-08-14
Approval details
- PMA number
- P030039
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2018-06-01
- Decision date
- 2020-08-14
- Days to decision
- 805 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- Approval for a design change to the applicator and changes to the manufacturing site and labeling to reflect the updated applicator.
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