| 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 | CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC & ATLAS ICD FAMILIES |
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| Classification Name | pulse generator, permanent, implantable |
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| Generic Name | transtelephonic follow-up/monitoring system |
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| Applicant | ST. JUDE MEDICAL, INC. |
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| PMA Number | P910023 |
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| Supplement Number | S163 |
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| Date Received | 12/06/2007 |
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| Decision Date | 01/04/2008 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Alternate method and material used to attach components on the icd/crt-d. |
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