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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP990001
Supplement NumberS002
Date Received10/12/1999
Decision Date11/12/1999
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-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.