PMA P110001S009

Device
RX HERCULINK ELITE RENAL STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S009
Product code
NIN
Decision date
2012-10-09
Generic name
STENT, RENAL
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ABBOTT VASCULAR CARDIAC THERAPIES IN CLONMEL, IRELAND.

Current openFDA PMA Record#

Device
RX HERCULINK ELITE RENAL STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S009
Product code
NIN
Generic name
STENT, RENAL
Decision date
2012-10-09
Decision code
APPR
Date received
2012-08-02
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 ABBOTT VASCULAR CARDIAC THERAPIES IN CLONMEL, IRELAND.