Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceDIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW, MN 55112
PMA NumberP990001
Date Received01/09/1999
Decision Date09/27/1999
Product Code NVZ 
Docket Number 99M-4281
Notice Date 10/20/1999
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S111 
S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 S123 
-
-