PMA P950034S008
- Device
- SEPRAFILM BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S008
- Product code
- MCN
- Decision date
- 1998-08-18
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- Approval for the extension of the expiration dating period for Seprafilm(R) Bioresorbable membrane from 24 monts to 30 months.
Current openFDA PMA Record#
- Device
- SEPRAFILM BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S008
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 1998-08-18
- Decision code
- APPR
- Date received
- 1998-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the extension of the expiration dating period for Seprafilm(R) Bioresorbable membrane from 24 monts to 30 months.