COSEAL SURGICAL SEALANT (PREMIXED)
FDA premarket approval P010022/S001 · decided 2003-02-04
Approval details
- PMA number
- P010022
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSEAL SURGICAL SEALANT (PREMIXED)
- Generic name
- Sealant, polymerizing
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2002-08-09
- Decision date
- 2003-02-04
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR: 1) CHANGE IN PACKAGING OF THE POLYMER RESINS TO A PRE-MIXED CONFIGURATION; 2) CHANGE IN BUFFER A TO A DILUTE HYDROGEN CHLORIDE SOLUTION WITH A PH OF 2.2; 3) CHANGE IN STERILIZATION TO GAMMA RADIATION; AND 4) CHANGE TO ROOM TEMPERATURE STORAGE.
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