PMA P130005S003
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S003
- Product code
- MCX
- Decision date
- 2014-09-26
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- CHANGE TO THE INCOMING QUALITY CONTROL INSPECTION FOR THE SALINE SHEATH ON THE ORBITAL ATHERECTOMY DEVICE (OAD).
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S003
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2014-09-26
- Decision code
- OK30
- Date received
- 2014-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE INCOMING QUALITY CONTROL INSPECTION FOR THE SALINE SHEATH ON THE ORBITAL ATHERECTOMY DEVICE (OAD).