Atlas FDA

TEMPO DR 2102 AND TEMP D 2902

FDA premarket approval P900070/S015 · decided 1996-11-27

Approval details

PMA number
P900070
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Other
Trade name
TEMPO DR 2102 AND TEMP D 2902
Generic name
implantable pacemaker Pulse-generator
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Date received
1996-11-06
Decision date
1996-11-27
Days to decision
21 days
Decision code
APPR
Product code
DXY
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
MODIFICATION TO THE LABELING REGARDING THE PROPER INSERTION OF A LEAD INTO THE CONNECTOR PORT

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510(k) clearances by this applicant

RecordFirmDate
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (K122090)St. Jude Medical, Cardiac Rhythm Management Divisi2012-11-15
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER (K120296)St. Jude Medical, Cardiac Rhythm Management Divisi2012-05-11
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (K120298)St. Jude Medical, Cardiac Rhythm Management Divisi2012-05-08
AGILLS PF DELIVERY SYSTEM (K111943)St. Jude Medical, Cardiac Rhythm Management Divisi2011-09-29
CPS DIRECT SL II SLITTABLE OUTER CATHETER (K103250)St. Jude Medical, Cardiac Rhythm Management Divisi2011-01-19
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (K093858)St. Jude Medical, Cardiac Rhythm Management Divisi2010-04-02
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 (K092075)St. Jude Medical, Cardiac Rhythm Management Divisi2009-08-07
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 Divisi2009-07-01