PMA P130005

Device: Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S035
Product code: MCX
Decision date: 2026-03-10
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: the adoption of Abbott Vascular (AV) environmental monitoring testing procedures for Abbott Vascular Houston (AVH) and Abbott Vascular St. Paul (AVSP) facilities and to replace the current supplier for environmental monitoring testing with Abbott Vascular Temecula (AVT) and Abbott Vascular Westford (AVW) as the laboratory testing sites

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: S051
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2026-03-10
Decision code: OK30
Date received: 2026-02-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the adoption of Abbott Vascular (AV) environmental monitoring testing procedures for Abbott Vascular Houston (AVH) and Abbott Vascular St. Paul (AVSP) facilities and to replace the current supplier for environmental monitoring testing with Abbott Vascular Temecula (AVT) and Abbott Vascular Westford (AVW) as the laboratory testing sites