- Device
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S090
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2020-09-04
- Decision code
- OK30
- Date received
- 2020-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of two Yokogawa paperless cycle recorders used in Lyophilizers 1 and 2 in Integras manufacturing facility.