PMA P130005S013
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S013
- Product code
- MCX
- Decision date
- 2016-06-07
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- Use an alternate supplier for a component used to construct the OAS Pump.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S013
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2016-06-07
- Decision code
- OK30
- Date received
- 2016-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an alternate supplier for a component used to construct the OAS Pump.