PMA P950034S031
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S031
- Product code
- MCN
- Decision date
- 2008-06-20
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- APPROVAL FOR THE ADDITION OF VISUAL REPRESENTATIONS OF THE DIRECTIONS FOR USE SECTION OF THE CURRENT APPROVED PACKAGE INSERT.
Current openFDA PMA Record#
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S031
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2008-06-20
- Decision code
- APPR
- Date received
- 2008-06-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF VISUAL REPRESENTATIONS OF THE DIRECTIONS FOR USE SECTION OF THE CURRENT APPROVED PACKAGE INSERT.