PMA P950034S016
- Device
- SEPRAFILM BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S016
- Product code
- MCN
- Decision date
- 2000-07-07
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST.
Current openFDA PMA Record#
- Device
- SEPRAFILM BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S016
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2000-07-07
- Decision code
- APPR
- Date received
- 2000-05-30
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST.