| 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 | PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T |
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| Classification Name | pulse generator, permanent, implantable |
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| Generic Name | implantable pacemaker pulse generator,pacemaker programmer |
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| Applicant | BIOTRONIK, INC. |
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| PMA Number | P950037 |
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| Supplement Number | S117 |
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| Date Received | 12/21/2012 |
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| Decision Date | 01/31/2013 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | real-time process |
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| Supplement Reason | change design/components/specifications - component |
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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 updates to the home monitoring service center with 5 software versions, v3. 8. 1, v3. 9. 0, v3. 10. 0, v3. 11. 0, v3. 12. 0; and the cardiomessenger ii9-llt). |
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