PMA N18286S035
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S035
- Product code
- LMF
- Decision date
- 2020-03-19
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change in the incoming specifications for the gelatin component.
Current openFDA PMA Record#
- Device
- Gelfoam (absorbable gelatin) Sterile Sponge
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S035
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2020-03-19
- Decision code
- OK30
- Date received
- 2020-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the incoming specifications for the gelatin component.