TEMPO AND META PULSE GENERATORS

FDA premarket approval P900070/S023 · decided 1998-10-15

Approval details

PMA number: P900070
Supplement: S023
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name: TEMPO AND META PULSE GENERATORS
Generic name: implantable pacemaker Pulse-generator
Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
Date received: 1998-09-09
Decision date: 1998-10-15
Days to decision: 36 days
Decision code: OK30
Product code: DXY
Advisory committee: Cardiovascular
Expedited review: No
Location: Sylmar, CA
Statement: The 30-day Notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.

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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