PMA N18286S033
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S033
- Product code
- LMF
- Decision date
- 2019-12-03
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Changes to the quality control testing used at the GELFOAM Brick crosslinked (sub-assembly) stage of the GEL-FLOW NT.
Current openFDA PMA Record#
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S033
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2019-12-03
- Decision code
- OK30
- Date received
- 2019-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the quality control testing used at the GELFOAM Brick crosslinked (sub-assembly) stage of the GEL-FLOW NT.