| 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 | EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR |
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| Classification Name | implantable cardioverter defibrillator (non-crt) |
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| Applicant | MEDTRONIC, INC. |
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| PMA Number | P980016 |
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| Supplement Number | S410 |
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| Date Received | 04/09/2013 |
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| Decision Date | 05/07/2013 |
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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
Seven previously approved manufacture changes for the devices. Those are: 1) update the cmos ic process flow changes at your supplier; 2) update the test software and hardware on the teradyne test platform for m019 and m017 ics; 3) add the high temperature monitor to high power lean line; 4) update the automated assembly equipment controller (aaec); 5) implement a new cleaning process and a curing oven; 6) implement a manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations; and 7) update to the test system software shell. |
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