• 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 NameSELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
Classification Namepermanent pacemaker electrode
Generic Nametransvenous unipolar/bipolar pacing lead
Regulation Number870.3680
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP950001
Supplement NumberS001
Date Received10/16/1996
Decision Date11/12/1996
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change in location pilot
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085 - this supplement reviewed under the pilot program and the approval only applies to the request for a new sterilization site.
-
-