Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
• Generic Name: Pulse generator, permanent, implantable
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P990001
• Date Received: 01/09/1999
• Decision Date: 09/27/1999
• Product Code: NVZ
• Docket Number: 99M-4281
• Notice Date: 10/20/1999
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• 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
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S089 S090 S091 S095 S096 S097 S098 S119 S105 S106 S107 ; S108 S082 S083 S084 S001 S002 S006 S015 S116 S099 S115 S109 ; S022 S023 S024 S025 S030 S031 S060 S055 S048 S049 S008 S009 ; S038 S039 S040 S041 S042 S043 S072 S073 S032 S033 S034 S020 ; S019 S005 S003 S004 S085 S086 S092 S093 S094 S087 S088 S101 ; S102 S103 S104 S111 S121 S112 S113 S114 S100 S118 S110 S120 ; S117 S080 S081 S012 S013 S014 S035 S036 S037 S027 S056 S061 ; S062 S063 S064 S074 S075 S076 S044 S045 S046 S047 S010 S011 ; S016 S017 S050 S051 S052 S053 S065 S066 S057 S077 S078 S079 ; S028 S029 S054 S067 S068 S069 S070 S071 S058 S059 S122