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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 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 NameMODEL 1256D META MV CARDIAC PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacing system
Regulation Number870.3610
ApplicantPACESETTER, INC.
PMA NumberP900070
Supplement NumberS019
Date Received04/14/1997
Decision Date04/29/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site for model 9602 programmer. The site is located at pacesetter, inc. , 15900 valley view ct. , sylmar, ca.
-
-