PMA P820018

Device: AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S073
Product code: LWP
Decision date: 2006-07-28
Generic name: Implantable pulse generator, pacemaker (non-CRT)
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: AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS
Applicant: St. Jude Medical, Inc.
PMA number: P820018
Supplement: S075
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2006-07-28
Decision code: APPR
Date received: 2006-02-17
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.