PMA P830061S058

Device: VITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S058
Product code: NVY
Decision date: 2010-11-23
Classification: Permanent Defibrillator Electrodes
Generic name: Permanent defibrillator electrodes
Approval order statement: IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.

Current openFDA PMA Record#

Device: VITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S058
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2010-11-23
Decision code: OK30
Date received: 2010-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.