Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form
FDA premarket approval P850010/S079 · decided 2018-02-09
Approval details
- PMA number
- P850010
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2018-01-11
- Decision date
- 2018-02-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Implement a peristaltic pump for use as a manufacturing aid in the Dispersion Preparation Process for 0.77% or 0.85% Alkali Dispersion at the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ.
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