HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S017 · decided 2002-04-03
Approval details
- PMA number
- P850010
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2002-03-15
- Decision date
- 2002-04-03
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR THE MARKETING OF THE HELITENE FIBRILS, IN A PAD FORM.
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