PMA P950034S041

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S041
Product code
MCN
Decision date
2012-04-04
Generic name
Barrier, absorbable, adhesion
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT GENZYME NORTHBOROUGH OPERATIONS CENTER (GNOC) IN NORTHBOROUGH, MASSACHUSETTS.

Current openFDA PMA Record#

Device
SEPRAFILM
Applicant
Baxter Healthcare Corporation
PMA number
P950034
Supplement
S041
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2012-04-04
Decision code
APPR
Date received
2012-02-16
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT GENZYME NORTHBOROUGH OPERATIONS CENTER (GNOC) IN NORTHBOROUGH, MASSACHUSETTS.