- Device
- Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S109
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2024-08-22
- Decision code
- OK30
- Date received
- 2024-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to replace the PC, the data acquisition system, and upgrade the software on the new PC