| 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 | ORCHESTRA PROGRAMMER |
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| Classification Name | defibrillator, implantable, dual-chamber |
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| Generic Name | implantable cardioverter-defibrillator with active housing |
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| Applicant | ELA MEDICAL, INC. |
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| PMA Number | P980049 |
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| Supplement Number | S011 |
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| Date Received | 09/23/2003 |
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| Decision Date | 10/21/2003 |
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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 - software |
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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 orchestra application software (elaview 1. 20 ug1) which allows high-speed telemetry and correct minor anomalies. |
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