PMA P170008S015

Device: EluNIR Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S015
Product code: NIQ
Decision date: 2019-04-12
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: Utilization of two identical welding machines for the welding of the D-Catheter Distal spring tip, as an alternative to the already approved welding machines used for this purpose.

Current openFDA PMA Record#

Device: EluNIR Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S015
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2019-04-12
Decision code: OK30
Date received: 2019-03-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Utilization of two identical welding machines for the welding of the D-Catheter Distal spring tip, as an alternative to the already approved welding machines used for this purpose.