SURGIFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval P990004/S023 · decided 2013-01-09
Approval details
- PMA number
- P990004
- Supplement
- S023
- Supplement type
- 135 Review Track For 30-Day Notice
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2012-10-22
- Decision date
- 2013-01-09
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR A CHANGE IN THE LOCATION OF THE FERROSAN MEDICAL DEVICES A/S (FEMD) TESTING LABORATORY IN SOEBORG, DENMARK.
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