• 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 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.
 
DeviceTENDRIL SDX
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
PACESETTER, INC.
15900 valley view ct.
p.o. box 9221
sylmar, CA 91392-9221
PMA NumberP960013
Supplement NumberS008
Date Received08/11/2000
Decision Date09/07/2000
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY AT STERIS ISOMEDIX, MINNEAPOLIS, MN.
-
-