- Device
- ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Applicant
- Coletica S.A.
- PMA number
- P930030
- Supplement
- S001
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 1995-11-30
- Decision code
- APPR
- Date received
- 1995-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A CHANGE IN TRADE NAME THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ACTIFOAM ABSORBABLE COLLAGEN HEMOSTATIC SPONGE