PMA P830061S106

Device: CAPSURE LEAD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S106
Product code: NVY
Decision date: 2014-02-04
Classification: Permanent Defibrillator Electrodes
Generic name: Permanent defibrillator electrodes
Approval order statement: ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.

Current openFDA PMA Record#

Device: CAPSURE LEAD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P830061
Supplement: S106
Product code: NVY
Generic name: Permanent defibrillator electrodes
Decision date: 2014-02-04
Decision code: OK30
Date received: 2014-01-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.