COSEAL SURGICAL SEALANT (COSEAL)
FDA premarket approval P010022 · decided 2001-12-14
Approval details
- PMA number
- P010022
- Trade name
- COSEAL SURGICAL SEALANT (COSEAL)
- Generic name
- Sealant, polymerizing
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2001-04-12
- Decision date
- 2001-12-14
- Days to decision
- 246 days
- Decision code
- APWD
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR THE COSEAL SURGICAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
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