- Device
- Helistat and Helitene Absorbable Collagen Hemostatic Agents
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S097
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-10-07
- Decision code
- APPR
- Date received
- 2021-04-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the manufacturing site of the product package supplier to Carolina, Puerto Rico