PMA N18286S026
- Device
- GELFOAM (ABSORBLE GELTON)STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S026
- Product code
- LMF
- Decision date
- 2014-04-09
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- CHANGES TO THE 10 ML PRE-FILLED 0.9% SODIUM CHLORIDE SOLUTION SYRINGE, PACKAGED WITHIN THE GELFOAM PLUS HEMOSTASIS KITS.
Current openFDA PMA Record#
- Device
- GELFOAM (ABSORBLE GELTON)STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S026
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-04-09
- Decision code
- OK30
- Date received
- 2014-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE 10 ML PRE-FILLED 0.9% SODIUM CHLORIDE SOLUTION SYRINGE, PACKAGED WITHIN THE GELFOAM PLUS HEMOSTASIS KITS.