PMA N18286S022
- Device
- GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S022
- Product code
- LMF
- Decision date
- 2012-02-29
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR A NEW CONVENIENCE KIT, GELFOAM PLUS ¿ POWDER TO BE COMPRISED OF GELFOAM POWDER, HUMAN THROMBIN, ONE SYRINGE THAT IS PRE-FILLED WITH 0.9% NAC1 SOLUTION, ONE EMPTY SYRINGE, A NEEDLELESS TRANSFER DEVICE AND AN APPLICATOR TIP.
Current openFDA PMA Record#
- Device
- GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S022
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2012-02-29
- Decision code
- APPR
- Date received
- 2011-09-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW CONVENIENCE KIT, GELFOAM PLUS ¿ POWDER TO BE COMPRISED OF GELFOAM POWDER, HUMAN THROMBIN, ONE SYRINGE THAT IS PRE-FILLED WITH 0.9% NAC1 SOLUTION, ONE EMPTY SYRINGE, A NEEDLELESS TRANSFER DEVICE AND AN APPLICATOR TIP.