COSEAL SURGICAL SEALANT
FDA premarket approval P030039/S005 · decided 2007-07-24
Approval details
- PMA number
- P030039
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2007-06-25
- Decision date
- 2007-07-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- EXPANSION OF THE ISO CLASS 7 CLEANROOM AND THE INSTALLATION OF A LARGER WATER DELIVERY PUMP.
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