COSEAL SURGICAL SEALANT
FDA premarket approval P030039 · decided 2003-12-12
Approval details
- PMA number
- P030039
- Trade name
- COSEAL SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Bio Science
- Date received
- 2003-07-16
- Decision date
- 2003-12-12
- Days to decision
- 149 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Round Lake,, IL
- Statement
- APPROVAL FOR REFERENCE RIGHTS TO P010022. THE DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
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