PMA P130005S048

Device: Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S048
Product code: MCX
Decision date: 2026-01-14
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: labeling updates to add IEC 60601 electrical safety warnings to the electronic Instructions for Use

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: S048
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2026-01-14
Decision code: APPR
Date received: 2025-12-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: labeling updates to add IEC 60601 electrical safety warnings to the electronic Instructions for Use