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 | VITATRON |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S028 |
Date Received | 02/26/2007 |
Decision Date | 07/10/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE VITATRON FAMILY APPLICATION SOFTWARE MODELS THAT SUPPORT THE DIVA, DEMA AND SELECTION AFM 902 DEVICES (VSC02 VERSION 9.1 SR1), C-SERIES DEVICES A1 MODELS (VSF04 VERSION 1.3), C-SERIES DEVICES A3 MODELS (VSF12 VERSION 1.2, AND T-SERIES DEVICES (VSF08 VERSION 1.6). THE MODIFICATIONS WILL UPDATE THE EMI BEHAVIOR OF YOUR DEVICE, CORRECT THE ISSUE OF DA+ INHIBITION OF PACING BELOW THE PROGRAMMED THRESHOLD, IDENTIFY TO THE USER INACCURATE COULOMB COUNTS, ALLOW THE APPLICATION SUITE TO BE SPLIT INTO SEVERAL APPLICATION PACKAGES, AND MINOR SOFTWARE ENHANCEMENTS. |
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