PMA P130005S035
- Device
- Diamondback 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S035
- Product code
- MCX
- Decision date
- 2022-03-11
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Introducing alternate suppliers for different non-patient-contacting device components.
Current openFDA PMA Record#
- Device
- Diamondback 360 Coronary Orbital Atherectomy System
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S035
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2022-03-11
- Decision code
- OK30
- Date received
- 2022-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introducing alternate suppliers for different non-patient-contacting device components.