PMA P110001S003

Device
RX HECULINK ELITE RENAL STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S003
Product code
NIN
Decision date
2012-06-26
Generic name
STENT, RENAL
Approval order statement
APPROVAL FOR POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
RX HECULINK ELITE RENAL STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P110001
Supplement
S003
Product code
NIN
Generic name
STENT, RENAL
Decision date
2012-06-26
Decision code
APPR
Date received
2012-04-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL FOR POST-APPROVAL STUDY PROTOCOL.