PMA P130005S044

Device: Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S044
Product code: MCX
Decision date: 2024-12-12
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: a change in cleanroom classification at the AVH TX and AVSP MN facilities

Current openFDA PMA Record#

Device: Diamondback 360 Orbital Atherectomy and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S044
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2024-12-12
Decision code: OK30
Date received: 2024-11-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change in cleanroom classification at the AVH TX and AVSP MN facilities