PMA P850010S114
- Device
- Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S114
- Product code
- LMF
- Decision date
- 2025-01-14
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change of supplier for Tyvek Lids and Rollstocks
Current openFDA PMA Record#
- Device
- Helitene® Absorbable Collagen Hemostatic Agent – Fibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P850010
- Supplement
- S114
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2025-01-14
- Decision code
- OK30
- Date received
- 2024-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of supplier for Tyvek Lids and Rollstocks