META & TEMPO PACEMAKERS

FDA premarket approval P900070/S034 · decided 2006-07-11

Approval details

PMA number: P900070
Supplement: S034
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Trade name: META & TEMPO PACEMAKERS
Generic name: Pulse generator, permanent, implantable
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Date received: 2006-06-07
Decision date: 2006-07-11
Days to decision: 34 days
Decision code: APPR
Product code: NVZ
Advisory committee: Cardiovascular
Expedited review: No
Location: Sylmar, CA
Statement: APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.

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Record	Firm	Date
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090)	St. Jude Medical, Cardiac Rhythm Management Divisi	2012-11-15
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER (K120296)	St. Jude Medical, Cardiac Rhythm Management Divisi	2012-05-11
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (K120298)	St. Jude Medical, Cardiac Rhythm Management Divisi	2012-05-08
AGILLS PF DELIVERY SYSTEM (K111943)	St. Jude Medical, Cardiac Rhythm Management Divisi	2011-09-29
CPS DIRECT SL II SLITTABLE OUTER CATHETER (K103250)	St. Jude Medical, Cardiac Rhythm Management Divisi	2011-01-19
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (K093858)	St. Jude Medical, Cardiac Rhythm Management Divisi	2010-04-02
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (K092075)	St. Jude Medical, Cardiac Rhythm Management Divisi	2009-08-07
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 (K090613)	St. Jude Medical, Cardiac Rhythm Management Divisi	2009-07-01