COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P810006/S026 · decided 2007-01-09
Approval details
- PMA number
- P810006
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2006-12-12
- Decision date
- 2007-01-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- CHANGE IN MANUFACTURING PROCESS FOR A QC RELEASE TEST FOR FINISHED DEVICES USED IN THE COLLAGEN PURIFICATION PROCESS.
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