COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P810006/S020 · decided 2001-07-05
Approval details
- PMA number
- P810006
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2001-06-08
- Decision date
- 2001-07-05
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.
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