| 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 | MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD, |
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| Classification Name | implantable pacemaker pulse-generator |
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| Generic Name | pulse generator |
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| Regulation Number | 870.3610 |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P890003 |
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| Supplement Number | S039 |
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| Date Received | 04/20/1995 |
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| Decision Date | 03/22/1996 |
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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 - other |
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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 medtronic thera vdd model 8968i and prodigy vdd model 8168 pulse generators, model 5032 capsure vdd lead, model 9879e software, and model 9759 memorymod. |
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