PMA P130005S046

Device: Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S046
Product code: MCX
Decision date: 2025-04-14
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: modifying the manufacturing electrical tests (Hi-Pot test) for the Orbital Atherectomy System Pump (OAS Pump) and adding a new functional test for the Hi-Pot tester cord.

Current openFDA PMA Record#

Device: Diamondback 360™ Coronary Orbital Atherectomy System, Diamondback 360 Precision™ Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S046
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2025-04-14
Decision code: OK30
Date received: 2025-03-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modifying the manufacturing electrical tests (Hi-Pot test) for the Orbital Atherectomy System Pump (OAS Pump) and adding a new functional test for the Hi-Pot tester cord.