• 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 NamePASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameendocardial pacing leads
Regulation Number870.3680
ApplicantPACESETTER, INC.
PMA NumberP960030
Supplement NumberS004
Date Received09/16/1998
Decision Date10/08/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested that fda review a change in material from etr and mdx silicone rubber to liquid silicone rubber, and a change in the manufacturing process, from transfer molding to liquid injection molding, using an approved vendor. These changes apply to the fins, tines, and suture sleeve components of the passive plus(r) endocardial pacing leads.
-
-