PMA P810006S020
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S020
- Product code
- LMF
- Decision date
- 2001-07-05
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.
Current openFDA PMA Record#
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S020
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2001-07-05
- Decision code
- APPR
- Date received
- 2001-06-08
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT.