SURGIFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval P990004/S015 · decided 2008-10-03
Approval details
- PMA number
- P990004
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2008-09-03
- Decision date
- 2008-10-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- ELIMINATION OF STERILITY TESTING AS PART OF THE STERILITY RELEASE PROCEDURE. THE RESULTS OF BIOBURDEN TESTING AND DRY HEAT STERILIZATION PROCESS PARAMETERS WILL CONTINUE TO BE REVIEWED AS PART OF THE STERILITY RELEASE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.