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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 OPTIM LEADS AND RIATA STS OPTIM LEADS AND
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP950022
Supplement NumberS041
Date Received08/22/2007
Decision Date10/16/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to modify the shock coil on the riata st optim and riata sts optim leads and to add two new passive lead models. The devices, as modified, will be marketed under the trade name riata st optim lead models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 and riata sts optim lead models 7120, 7121,7122, 7130, 7131, 7170 and 7171 and are indicated for use with compatible pulse generators (refer to the applicable defibrillator manul for system indications). They provide pacing and sensing and deliver cardioversion/ defibrillation therapy to the heart.
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