| 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 | PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE |
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| Classification Name | implantable pulse generator, pacemaker (non-crt) |
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| Generic Name | cardiac resynchronization therapy defibrillator (crt-d) system |
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| Applicant | GUIDANT CORP. |
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| PMA Number | P960040 |
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| Supplement Number | S127 |
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| Date Received | 05/12/2006 |
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| Decision Date | 08/25/2006 |
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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 | labeling change - instructions |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
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