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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
Classification Namepulse generator, permanent, implantable
Applicant MEDTRONIC INC.
PMA NumberP990001
Date Received01/09/1999
Decision Date09/27/1999
Product Code
NVZ[ Registered Establishments with NVZ ]
Docket Number 99M-4281
Notice Date 10/20/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the diva platform implantable pulse generators and the provit iii application software (version 3. 3. 2) including the diamond ii model 820 pulse generator; the ruby ii model 720 pulse generator; the topaz ii model 520 pulse generator; the jade ii model 220 pulse generator; the vita ddr moel 810 pulse generator; the vita ddd model 710 pulse generator; the vita vvir model 310 pulse generator.
Approval Order Approval Order
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