- Device
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S096
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-11-13
- Decision code
- APPR
- Date received
- 2021-05-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the qualification of an additional abattoir (harvesting facility) for New Zealand sourced bovine tendon.