FDA.reportPublic FDA data

PMA P110004S017

Device
NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)
Applicant
Medinol, Ltd.
PMA number
P110004
Supplement
S017
Product code
MAF
Decision date
2016-06-24
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
Approval of the following changes to the post-approval study for the device: revisions to the exclusion criteria and clarification of the serious adverse event definition.

Current openFDA PMA Record#

Device
NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)
Applicant
Medinol, Ltd.
PMA number
P110004
Supplement
S017
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2016-06-24
Decision code
APPR
Date received
2016-04-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
Approval of the following changes to the post-approval study for the device: revisions to the exclusion criteria and clarification of the serious adverse event definition.