- Device
- Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S111
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2024-07-24
- Decision code
- OK30
- Date received
- 2024-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of the Vaisala viewLinc Countinous Monitoring system for temperature and relative humidity monitoring of manufacturing cleanrooms and laboratory rooms at the Integra NeuroSciences Anasco, PR facility