PMA N18286S021
- Device
- GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S021
- Product code
- LMF
- Decision date
- 2011-07-09
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT GELFOAM PLUS COMPRESSED. THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE. THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY. THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROMBIN TO A PHYSICIAN DURING SURGERY.
Current openFDA PMA Record#
- Device
- GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE
- Applicant
- Pfizer, Inc.
- PMA number
- N18286
- Supplement
- S021
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2011-07-09
- Decision code
- APPR
- Date received
- 2011-05-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN SOME OF THE COMPONENTS CONTAINED IN THE GELFOAM PLUS KIT AS WELL AS THE INTRODUCTION OF AN ALTERNATIVE GELFOAM PLUS KIT GELFOAM PLUS COMPRESSED. THE COMPONENT CHANGES WILL SUBSTITUTE PREFILLED SALINE SYRINGES AND A NEEDLELESS TRANSFER DEVICE FOR THE STANDARD SALINE VIALS AND NEEDLE-SYRINGE. THE COMPONENTS HAVE BEEN CLEARED/ APPROVED PREVIOUSLY. THE PURPOSE OF THE GELFOAM PLUS KIT IS TO PROVIDE THE CONVENIENCE OF CO-PACKAGED COLLAGEN SPONGE, SALINE DILUENT AND HUMAN THROMBIN TO A PHYSICIAN DURING SURGERY.