Surgifoam Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S032 · decided 2017-09-21
Approval details
- PMA number
- P990004
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surgifoam Absorbable Gelatin Sponge, U.S.P.
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2017-08-25
- Decision date
- 2017-09-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Addition of a new secondary packaging site: Ferrosan Medical Devices Sp. z o.o.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.