FDA.reportPublic FDA data

PMA P050011S006

Device
ADEPT Adhesion Reduction Solution
Applicant
Baxter Healthcare Corp
PMA number
P050011
Supplement
S006
Product code
MCN
Decision date
2019-06-03
Classification
Barrier, Absorbable, Adhesion
Generic name
Barrier, absorbable, adhesion
Approval order statement
Approval for a transfer of the design-owning organization from Baxter AG Vienna, Austria to Baxter Alliance Park Braine-L'Alleud, Belgium and final release testing and product release functions from Baxter AG Vienna, Austria to Baxter Castlebar, Ireland for the ADEPT Adhesion Reduction Solution.

Current openFDA PMA Record#

Device
ADEPT Adhesion Reduction Solution
Applicant
Baxter Healthcare Corp
PMA number
P050011
Supplement
S006
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2019-06-03
Decision code
APPR
Date received
2017-05-17
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a transfer of the design-owning organization from Baxter AG Vienna, Austria to Baxter Alliance Park Braine-L'Alleud, Belgium and final release testing and product release functions from Baxter AG Vienna, Austria to Baxter Castlebar, Ireland for the ADEPT Adhesion Reduction Solution.