PMA P950034S045
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S045
- Product code
- MCN
- Decision date
- 2016-01-14
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- AN EXTENSION OF THE POST-DHT DRY HEAT TREATMENT MAXIMUM HOLD TIME FOR YOUR SEPRAFILM ADHESION BARRIER DEVICE.
Current openFDA PMA Record#
- Device
- SEPRAFILM ADHESION BARRIER
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S045
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2016-01-14
- Decision code
- OK30
- Date received
- 2015-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN EXTENSION OF THE POST-DHT DRY HEAT TREATMENT MAXIMUM HOLD TIME FOR YOUR SEPRAFILM ADHESION BARRIER DEVICE.