PMA P130005S001
- Device
- DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S001
- Product code
- MCX
- Decision date
- 2014-10-29
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE DEVICE OR USE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CONONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S001
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2014-10-29
- Decision code
- APPR
- Date received
- 2014-07-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE DEVICE OR USE OF THE DEVICE.