PMA P110004S002

Device
NIRXCELL COCR CORONARY STENT ON RX SYSTEM
Applicant
Medinol, Ltd.
PMA number
P110004
Supplement
S002
Product code
MAF
Decision date
2014-05-01
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
APPROVAL FOR A MODIFICATION TO THE D-CATHETER TIP SPRING.

Current openFDA PMA Record#

Device
NIRXCELL COCR CORONARY STENT ON RX SYSTEM
Applicant
Medinol, Ltd.
PMA number
P110004
Supplement
S002
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2014-05-01
Decision code
APPR
Date received
2014-02-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFICATION TO THE D-CATHETER TIP SPRING.