PMA P130005S045
- Device
- DIAMONDBACK 360® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S045
- Product code
- MCX
- Decision date
- 2025-04-24
- Classification
- Cardiovascular
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Change to include alternate Tyvek pouch coating material suppliers
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360® and Diamondback 360 Precision™ Coronary Orbital Atherectomy System (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S045
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2025-04-24
- Decision code
- OK30
- Date received
- 2025-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to include alternate Tyvek pouch coating material suppliers