| 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 ENTRUST MODELS D153ATG, D153DRG,D153VRC,D254ATG,D154DRG,D154VRC |
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| Classification Name | implantable cardioverter defibrillator (non-crt) |
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| Generic Name | dual chamber icds |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P980016 |
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| Supplement Number | S065 |
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| Date Received | 01/09/2006 |
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| Decision Date | 02/22/2006 |
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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 medtronic model 9987 application software version 1. 3 and version 1. 5 for medtronic enrhythm ipg and entrust icd systems. |
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