| 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 | ICD/CRT PARADYM R AND DR, PARADYM CRT-D, PARADYM RF-VR AND DR |
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| Classification Name | defibrillator, implantable, dual-chamber |
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| Generic Name | implantable cardioverter-defibrillator with active housing |
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| Applicant | SORIN CRM USA, INC. |
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| PMA Number | P980049 |
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| Supplement Number | S075 |
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| Date Received | 07/05/2012 |
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| Decision Date | 07/30/2012 |
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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
Moved component assembly step, removal of an optional cleaning step and alternative component attachment inspection equipment. |
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