PMA P170008S056

Device: EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S056
Product code: NIQ
Decision date: 2025-10-02
Classification: Cardiovascular
Generic name: Coronary drug-eluting stent
Approval order statement: a sampling plan that reduces sample size of the incoming inspections for raw materials and components of the EluNIR-PERL Ridaforolimus Eluting Coronary Stent System

Current openFDA PMA Record#

Device: EluNIR™ Ridaforolimus Eluting Coronary Stent System
Applicant: Medinol, Ltd.
PMA number: P170008
Supplement: S056
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2025-10-02
Decision code: APPR
Date received: 2025-02-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a sampling plan that reduces sample size of the incoming inspections for raw materials and components of the EluNIR-PERL Ridaforolimus Eluting Coronary Stent System