PMA P900070

Device: META AND TEMPO PACEMAKERS
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
PMA number: P900070
Supplement: S030
Product code: NVZ
Decision date: 2006-07-28
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.

Current openFDA PMA Record#

Device: META AND TEMPO PACEMAKERS
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
PMA number: P900070
Supplement: S030
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2006-07-28
Decision code: APPR
Date received: 2006-02-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODIFICATIONS TO THE PROGRAMMER SOFTWARE, MODEL 3307 V6.1.1C AND MODEL 3330 V4.1.1, TO INCLUDE THE QUICKOPT TIMING CYCLE FEATURE.