Premarket Approval (PMA)

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 Name: DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
• Classification Name: pulse generator, permanent, implantable
• Applicant: MEDTRONIC INC.
• PMA Number: P990001
• Date Received: 01/09/1999
• Decision Date: 09/27/1999
• 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

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

• Supplements: S001 S002 S003 S004 S005 S006 ; S008 S009 S010 S011 S012 S013 ; S014 S015 S016 S017 S019 S020 ; S022 S023 S024 S025 S027 S028 ; S029 S030 S031 S032 S033 S034 ; S035 S036 S037 S038 S039 S040 ; S041 S042 S043 S044 S045 S046 ; S047 S048 S049 S050 S051 S052 ; S053 S054 S055 S056 S057 S058 ; S059 S060 S061 S062 S063 S064 ; S065 S066 S067 S068 S069 S070 ; S071 S072 S073 S074 S075 S076 ; S077 S078 S079 S080 S081 S082 ; S083 S084 S085 S086 S087 S088 ; S089 S090 S091 S092 S093 S094 ; S095 S096 S097 S098 S099 S100 ; S101 S102 S103 S104 S105 S106 ; S107 S108 S109 S110