COLLASTAT HEMO SPONGE CHANGE IN PACKAGING
FDA premarket approval P810006/S016 · decided 1993-11-01
Approval details
- PMA number
- P810006
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLLASTAT HEMO SPONGE CHANGE IN PACKAGING
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1992-06-24
- Decision date
- 1993-11-01
- Days to decision
- 495 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
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