| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | TEMPO VR 1102 AND TEMPO V 1902 |
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| Classification Name | implantable pacemaker pulse-generator |
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| Generic Name | cardiac pacing system |
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| Regulation Number | 870.3610 |
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| Applicant | PACESETTER, INC. |
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| PMA Number | P900070 |
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| Supplement Number | S017 |
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| Date Received | 02/26/1997 |
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| Decision Date | 08/27/1997 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - color additive |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order 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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