PMA P990004S007
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S007
- Product code
- LMF
- Decision date
- 2005-01-07
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT ISOTRON PLC, SWINDON, UNITED KINGDOM.
Current openFDA PMA Record#
- Device
- SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P
- Applicant
- Ferrosan Meidcal Devices A/S
- PMA number
- P990004
- Supplement
- S007
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2005-01-07
- Decision code
- APPR
- Date received
- 2004-11-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT ISOTRON PLC, SWINDON, UNITED KINGDOM.