Atlas FDA

R5.111WE(REVISION OF R5.85WE)

FDA premarket approval P900070/S025 · decided 1999-09-24

Approval details

PMA number
P900070
Supplement
S025
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
R5.111WE(REVISION OF R5.85WE)
Generic name
implantable pacemaker Pulse-generator
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Date received
1999-09-07
Decision date
1999-09-24
Days to decision
17 days
Decision code
APPR
Product code
DXY
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.

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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