FDA.reportPublic FDA data

PMA P130005S032

Device
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
Applicant
Cardiovascular Systems, Inc.
PMA number
P130005
Supplement
S032
Product code
MCX
Decision date
2021-01-14
Generic name
CATHETER, CORONARY, ATHERECTOMY
Approval order statement
New sterilization cycle with a mixed sterilization load using Chamber 12 at the Minneapolis, MN sterilization facility and Chambers 1 & 4 at the El Paso, TX sterilization facility.

Current openFDA PMA Record#

Device
DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
Applicant
Cardiovascular Systems, Inc.
PMA number
P130005
Supplement
S032
Product code
MCX
Generic name
CATHETER, CORONARY, ATHERECTOMY
Decision date
2021-01-14
Decision code
OK30
Date received
2020-12-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New sterilization cycle with a mixed sterilization load using Chamber 12 at the Minneapolis, MN sterilization facility and Chambers 1 & 4 at the El Paso, TX sterilization facility.