PMA P130005S049

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S049
Product code: MCX
Decision date: 2026-02-18
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: implementing duplicate overmold equipment and updating the equipment parameters for the Diamondback 360 and Diamondback 360 Precision Coronary Orbital Atherectomy Device (OAD)

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S049
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2026-02-18
Decision code: OK30
Date received: 2026-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementing duplicate overmold equipment and updating the equipment parameters for the Diamondback 360 and Diamondback 360 Precision Coronary Orbital Atherectomy Device (OAD)