PMA P130005S004

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S004
Product code: MCX
Decision date: 2015-05-14
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: APPROVAL FOR A CHANGE TO THE SEALING PROCESS FOR THE NOSECONE-TO-GLUE PLUG AND GLUE PLUG-TO-SALINE SHEATH BONDS TO USE LIGHT WITHIN A NARROWER ULTRAVIOLET (UV) WAVELENGTH FOR CURING THE SEALING ADHESIVE.

Current openFDA PMA Record#

Device: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)
Applicant: Cardiovascular Systems, Inc.
PMA number: P130005
Supplement: S004
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2015-05-14
Decision code: APPR
Date received: 2014-12-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE SEALING PROCESS FOR THE NOSECONE-TO-GLUE PLUG AND GLUE PLUG-TO-SALINE SHEATH BONDS TO USE LIGHT WITHIN A NARROWER ULTRAVIOLET (UV) WAVELENGTH FOR CURING THE SEALING ADHESIVE.