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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameRIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS027
Date Received02/10/2006
Decision Date03/07/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) modifications to the riata st models 7000, 7001 and 7002 active-fixation defibrillation leads to change the geometric profile of the inner coil and add white pigment to the medical adhesive used for shock coil backfill. 2) modifications to the riata st models 7000, 7001, and 7002 leads to create an active-fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names riata st models 7010, 7011, and 7012 and are indicated for use with compatible pulse generators. 3) modifications to the riata st models 7000, 7001, and 7002 to create a passive fixation and a passive fixation integrated bipolar lead. These devices, as modified, will be marketed under the trade names riata st models 7040, 7041 and 7042 (passive fixation) and riata st models 7050, 7051, 7052 (passive fixation integrated bipolar) and are indicated for use with compatible pulse generators.
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