PMA P950034S043

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S043
Product code
MCN
Decision date
2015-12-03
Classification
Barrier, Absorbable, Adhesion
Generic name
Barrier, absorbable, adhesion
Approval order statement
A CHANGE IN THE SOFTWARE USED TO MANAGE AND PRINT BARCODES AND LABELS FOR THE SEPRAFILM ADHESION BARRIER DEVICE.

Current openFDA PMA Record#

Device
SEPRAFILM ADHESION BARRIER
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S043
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2015-12-03
Decision code
OK30
Date received
2015-10-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
A CHANGE IN THE SOFTWARE USED TO MANAGE AND PRINT BARCODES AND LABELS FOR THE SEPRAFILM ADHESION BARRIER DEVICE.