PMA P130005S029
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S029
- Product code
- MCX
- Decision date
- 2020-06-18
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval for performing certain manufacturing processes for the 1.25mm Classic Crown OAD assembly internally.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S029
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2020-06-18
- Decision code
- APPR
- Date received
- 2020-03-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for performing certain manufacturing processes for the 1.25mm Classic Crown OAD assembly internally.