PMA P130005S011
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S011
- Product code
- MCX
- Decision date
- 2016-03-16
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Use for an additional sterilization chamber for the ViperWire component.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S011
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2016-03-16
- Decision code
- OK30
- Date received
- 2016-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use for an additional sterilization chamber for the ViperWire component.