- Device
- Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent – Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S095
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-09-07
- Decision code
- APPR
- Date received
- 2021-03-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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