PMA P130005S009
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S009
- Product code
- MCX
- Decision date
- 2015-06-25
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE SEAL ON COMPONENTS OF THE ORBITAL ATHERECTOMY DEVICE (OAD).
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S009
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2015-06-25
- Decision code
- APPR
- Date received
- 2015-04-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE SEAL ON COMPONENTS OF THE ORBITAL ATHERECTOMY DEVICE (OAD).