PMA P130005S015

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S015
Product code: MCX
Decision date: 2017-02-23
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: Approval for a manufacturing site located at Isomedix Operations, Inc., 1435 Isomedix Place El Paso, TX 79936, Contract sterilizer.

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S015
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2017-02-23
Decision code: APPR
Date received: 2016-11-28
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 Isomedix Operations, Inc., 1435 Isomedix Place El Paso, TX 79936, Contract sterilizer.