| 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 | EPIC PLUS VR/DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
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| Classification Name | programmer, pacemaker |
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| Generic Name | cardiac pacemaker |
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| Regulation Number | 870.3700 |
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| Applicant | ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D |
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| PMA Number | P830045 |
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| Supplement Number | S084 |
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| Date Received | 02/07/2003 |
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| Decision Date | 04/23/2003 |
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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 model 3307 version 4. 3a programmer software. |
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