Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form
FDA premarket approval P850010/S095 · decided 2021-09-07
Approval details
- PMA number
- P850010
- Supplement
- S095
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2021-03-30
- Decision date
- 2021-09-07
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Approval for the removal of Heavy Metals testing from the routine monitoring of their Purified Water System used in the product manufacturing at their Puerto Rico facility
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