• 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 | Inspections
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 NameINSIGNIA AND CONTAK RENEWAL TR PULSE GENERATORS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namecardiac resynchronization therapy pacemaker (crt-p)
ApplicantGUIDANT CORP.
PMA NumberP030005
Supplement NumberS055
Date Received11/26/2008
Decision Date01/23/2009
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) replacement of the polymide tubing with polyetheretherktone (peek) tubing on the pulse generator pg header assemblies; 2) the use of a combination of natural and colorized peek to assist manufacturing operators; and 3) the addition of an extra plasma cleaning step to ensure that the bond formed between the medical adhesive applied to the base of the wire and the peek insulation is strong.
-
-