TEMPO DR 2102 AND TEMP D 2902
FDA premarket approval P900070/S014 · decided 1997-08-27
Approval details
- PMA number
- P900070
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 1996-09-16
- Decision date
- 1997-08-27
- Days to decision
- 345 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Tempo DR Model 2102, Tempo D Model 2902, Tempo VR Model 1102, and Tempo V Model 1902 Pulse Generators.
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