NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT
FDA premarket approval P850023/S002 · decided 1987-01-29
Approval details
- PMA number
- P850023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Datascope Corp.
- Date received
- 1986-10-29
- Decision date
- 1987-01-29
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Wayne, NJ
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