| 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 | BIOTRONIK GEMNOS 04 AND GEMNOS TC O4 |
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| Classification Name | implantable pulse generator, pacemaker (non-crt) |
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| Generic Name | implantable, unipolar, multiprogrammable pulse g |
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| Applicant | BIOTRONIK, INC. |
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| PMA Number | P820076 |
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| Supplement Number | S018 |
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| Date Received | 02/27/1995 |
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| Decision Date | 11/21/1996 |
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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
Use of self-sealing header and spring contactor, which replaces the current header design utilizing separable setscrews and sealing caps. |
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