COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S001 · decided 2004-01-12
Approval details
- PMA number
- P030039
- Supplement
- S001
- 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
- 2003-12-18
- Decision date
- 2004-01-12
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION, BAXTER BIOSCIENCES, DIVISION, FREMONT, CALIFORNIA.
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