- Device
- Collastat Absorbable Collagen Hemostatic Sponge
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S083
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-06-14
- Decision code
- APPR
- Date received
- 2018-10-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of a new instrument to calculate the percent solids of Alkali Dispersions.