COSEAL SURGICAL SEALANT, PREMIXED
FDA premarket approval P030039/S002 · decided 2006-11-03
Approval details
- PMA number
- P030039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSEAL SURGICAL SEALANT, PREMIXED
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2006-01-17
- Decision date
- 2006-11-03
- Days to decision
- 290 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, HAYWARD, CALIFORNIA.
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