- Device
- Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S115
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2026-09-18
- Decision code
- OK30
- Date received
- 2026-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system