PMA P110004S032

Device: NIRxcell CoCr Coronary Stent on RX System
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S032
Product code: MAF
Decision date: 2019-04-12
Classification: Stent, Coronary
Generic name: STENT, CORONARY
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: NIRxcell CoCr Coronary Stent on RX System
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S032
Product code: MAF
Generic name: STENT, CORONARY
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.