Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | INSYNC 8040 DEVICES |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S014 |
Date Received | 08/23/2004 |
Decision Date | 09/15/2004 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO UPDATE THE LONGEVITY PROJECTIONS FOR THE MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847 SOFTWARE FOR 7968-I THERA DR DEVICE AND MODEL 9980 SOFTWARE FOR THE INSYNC 8040 DEVICE. |
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