- Device
- Helistat, Helitene Absorbable Collagen Hemostatic Agents
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S081
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2018-05-17
- Decision code
- OK30
- Date received
- 2018-04-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the environmental monitoring procedures for detection of bioburden at the main cleanroom manufacturing area.