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Device | VITATRON DIVA IMPLANTABLE PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S002 |
Date Received | 10/12/1999 |
Decision Date | 11/12/1999 |
Product Code |
DXY |
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 Diva family implantable pulse generator: adding the following new models: Diamond II Model 820E; Ruby II Model 720E; Topaz II Model 520E; Jade II Model 220E; vita DDDr Model 810E; Vita DDD Model 710E; Vita VVIR Model 310E. Introduction of 3.2mm models the Diamond II Model 822E and Topaz II Model 522E; modifying the programmer software to recognize the new model numbers; modifying the header to be consistent with the Medtronic Kappa 400; move to mulitple feedthroughs from a single feedthrough design; change the tissue contracting materials and packaging to those currently used in Medtronic's Kappa 400; and modify the labeling to accommoate the additional models and attendant software changes. |