COSEAL SURGICAL SEALANT (PREMIXED)
FDA premarket approval P030039/S004 · decided 2007-05-11
Approval details
- PMA number
- P030039
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSEAL SURGICAL SEALANT (PREMIXED)
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2006-04-05
- Decision date
- 2007-05-11
- Days to decision
- 401 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR THE ADDITION OF THE COSEAL SPRAY DELIVERY SYSTEM WITH A SPRAY SET AND PRESSURE REGULATOR.
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