| 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 | VENTAK AV/ PRIZM/PRIZM2/ VITALITY |
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| Classification Name | programmer, pacemaker |
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| Generic Name | cardiac resynchronization therapy defibrillator (crt-d) system |
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| Regulation Number | 870.3700 |
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| Applicant | GUIDANT CORP. |
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| PMA Number | P960040 |
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| Supplement Number | S040 |
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| Date Received | 01/13/2004 |
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| Decision Date | 02/10/2004 |
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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: sterilization |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Change from the use of biological indicators as the sterilization release mechanism, to the use of parametric release. |
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