PMA P810006S056
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S056
- Product code
- LMF
- Decision date
- 2014-10-22
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- USE OF AN UPDATED QUALITY CONTROL TEST METHOD.
Current openFDA PMA Record#
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S056
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-10-22
- Decision code
- OK30
- Date received
- 2014-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN UPDATED QUALITY CONTROL TEST METHOD.