PMA P990004S013
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S013
- Product code
- LMF
- Decision date
- 2007-12-27
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE UROLOGIC PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.
Current openFDA PMA Record#
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S013
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2007-12-27
- Decision code
- APPR
- Date received
- 2007-07-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE UROLOGIC PROCEDURES EXCLUSION FROM THE INDICATIONS STATEMENT.