PMA P130005S007
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S007
- Product code
- MCX
- Decision date
- 2015-11-30
- Classification
- Catheter, Coronary, Atherectomy
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARDIOVASCULAR SYSTEMS INC., IN ST. PAUL, MINNESOTA.
Current openFDA PMA Record#
- Device
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- Applicant
- Cardiovascular Systems, Inc.
- PMA number
- P130005
- Supplement
- S007
- Product code
- MCX
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Decision date
- 2015-11-30
- Decision code
- APPR
- Date received
- 2015-02-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARDIOVASCULAR SYSTEMS INC., IN ST. PAUL, MINNESOTA.