PMA P130005S012
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S012
- Product code
- MCX
- Decision date
- 2016-10-26
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Approval to add heat/light stabilizers to the PEBAX used to construct the Saline Sheaths of the OAD.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S012
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2016-10-26
- Decision code
- APPR
- Date received
- 2016-03-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add heat/light stabilizers to the PEBAX used to construct the Saline Sheaths of the OAD.