• 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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP950022
Supplement NumberS014
Date Received01/31/2002
Decision Date03/11/2002
Product Code
LWS[ Registered Establishments with LWS ]
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 new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name riat series 1500 (models 1570, 1571, 1580 and 1581) defibrillation lead system and accessories (s-65-s, s-65-f, s-65-x, tx-070). These devices are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications. ). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.