• 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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Namepulse-generator, single chamber, single
Generic Namepulse-generator, single chamber, single
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP860007
Supplement NumberS020
Date Received05/19/1998
Decision Date07/06/1998
Product Code
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate Polyethylene Terephthalate Glycol (PETG) packaging material for the Intetach II, Model 262-16 pulse generator.