PMA P950034S050

Device
Seprafilm Adhesion Barrier
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S050
Product code
MCN
Decision date
2018-03-09
Classification
Barrier, Absorbable, Adhesion
Generic name
Barrier, absorbable, adhesion
Approval order statement
Implementation of a new casting machine.

Current openFDA PMA Record#

Device
Seprafilm Adhesion Barrier
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S050
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2018-03-09
Decision code
OK30
Date received
2018-02-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a new casting machine.