PARAGON/PHOENIX FAMILY OF PACEMAKERS

FDA premarket approval P830045/S109 · decided 2007-05-09

Approval details

PMA number: P830045
Supplement: S109
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Trade name: PARAGON/PHOENIX FAMILY OF PACEMAKERS
Generic name: Pulse generator, permanent, implantable
Applicant: St. Jude Medical, Inc.
Date received: 2007-04-23
Decision date: 2007-05-09
Days to decision: 16 days
Decision code: APPR
Product code: NVZ
Advisory committee: Cardiovascular
Expedited review: No
Location: Sylmar, CA
Statement: APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WI

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