PMA P830061S063

Device: CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S063
Product code: NVY
Decision date: 2011-05-19
Classification: Permanent Defibrillator Electrodes
Generic name: Permanent defibrillator electrodes
Approval order statement: USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.

Current openFDA PMA Record#

Device: CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/EXCELLENCE PS+
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S063
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2011-05-19
Decision code: OK30
Date received: 2011-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS.