PMA P850010S075
- Device
- Helistat Absorbable Collagen Hemostatic Agent and Helitene- Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S075
- Product code
- LMF
- Decision date
- 2017-04-24
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change in the tissue grinder.
Current openFDA PMA Record#
- Device
- Helistat Absorbable Collagen Hemostatic Agent and Helitene- Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S075
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2017-04-24
- Decision code
- OK30
- Date received
- 2017-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the tissue grinder.