PMA P850010S100
- Device
- Helistat and Helitene Absoibable Collagen Hemostatic Agents
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S100
- Product code
- LMF
- Decision date
- 2022-04-20
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Relocation of the supplier site for Tyvek envelope processing.
Current openFDA PMA Record#
- Device
- Helistat and Helitene Absoibable Collagen Hemostatic Agents
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S100
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2022-04-20
- Decision code
- OK30
- Date received
- 2022-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the supplier site for Tyvek envelope processing.