PMA P130005S047

Device: Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S047
Product code: MCX
Decision date: 2025-06-03
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: to add an in-process inspection to verify weld integrity on the crown-shaft subassemblies

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: S047
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2025-06-03
Decision code: OK30
Date received: 2025-04-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add an in-process inspection to verify weld integrity on the crown-shaft subassemblies