COLLASTAT
FDA premarket approval P810006/S012 · decided 1989-12-19
Approval details
- PMA number
- P810006
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLLASTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1989-04-24
- Decision date
- 1989-12-19
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
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