PMA P110004S024

Device: NIRxcell CoCr Coronary Stent on RX System
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S024
Product code: MAF
Decision date: 2018-03-07
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: Approval for a manufacturing site located at Creganna Medical, 8 Admiralty Street, #07-10 Admirax Building, Singapore, for the manufacturing of D-Catheter delivery system.

Current openFDA PMA Record#

Device: NIRxcell CoCr Coronary Stent on RX System
Applicant: Medinol, Ltd.
PMA number: P110004
Supplement: S024
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2018-03-07
Decision code: APPR
Date received: 2017-07-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Creganna Medical, 8 Admiralty Street, #07-10 Admirax Building, Singapore, for the manufacturing of D-Catheter delivery system.