COSEAL SURGICAL SEALANT & ACCESSORIES
FDA premarket approval P030039/S015 · decided 2010-04-05
Approval details
- PMA number
- P030039
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSEAL SURGICAL SEALANT & ACCESSORIES
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2010-03-02
- Decision date
- 2010-04-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR CHANGES TO THE LABELING TO ADDRESS SAFETY-RELATED INFORMATION TO BRING THE LABELING INTO COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICE DIRECTIVE MDD 2007/47/EC.
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