| 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, CANTOUR, ANGSTROM, PROFILE,PHOTON, EPIC AND 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 | S107 |
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| Date Received | 04/26/2006 |
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| Decision Date | 05/23/2006 |
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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
Use of an alternate encapsulant material in icd/crt-d hybrid production. |
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