HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S019 · decided 2006-09-20
Approval details
- PMA number
- P850010
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2005-09-30
- Decision date
- 2006-09-20
- Days to decision
- 355 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT INTEGRA NEUROSCIENCES PR, INC., ANASCO, PUERTO RICO FOR PACKAGING AND STERI-TECH, INC., SALINAS, PUERTO RICO FOR STERILIZATION.
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