- Device
- Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent- Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S084
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-03-15
- Decision code
- OK30
- Date received
- 2019-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement for the tendon slicer at the Collagen Manufacturing Center (CMC) Building.