• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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.
 
Trade NameVISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP840068
Supplement NumberS019
Date Received05/05/1992
Decision Date06/19/1996
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two new models of vista ddd pulse generators and a software module. The devices as modified will be marketed under the trade name vista ddd model 942, vista ddd model 944 and software module model 2052 with the commercially available handheld programmer model 2035.
-
-