COSEAL SURGICAL SEALANT
FDA premarket approval P010022/S002 · decided 2003-03-18
Approval details
- PMA number
- P010022
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2003-03-05
- Decision date
- 2003-03-18
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR A LABELING CHANGE TO ADD A BOXED WARNING REGARDING SWELL VOLUMES OF THE SEALANT.
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