Atlas FDA

TEMPO PULSE GENERATORS

FDA premarket approval P900070/S021 · decided 1997-10-16

Approval details

PMA number
P900070
Supplement
S021
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
TEMPO PULSE GENERATORS
Generic name
implantable pacemaker Pulse-generator
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Date received
1997-09-29
Decision date
1997-10-16
Days to decision
17 days
Decision code
APPR
Product code
DXY
Advisory committee
Cardiovascular
Expedited review
No
Location
Sylmar, CA
Statement
Approval for an alternate manufacturing facility located at Pacesetter, Inc., St. Jude Medical cardiac Rhythm Management Division, 15900 Valley View Court, Sylmar CA.

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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