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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 STS OPTIM LEAD MODELS 7120, 7121,7122,7130 AND 7131
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametransvenous defibrillation lead
PMA NumberP950022
Supplement NumberS040
Date Received07/06/2007
Decision Date09/06/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for distal tip changes to the riata st optim lead family. The device, as modified, will be marketed under the trade name riata sts optim lead models 7120, 7121, 7122, 7130 and 7131, and are indicated for use as transvenous, steroid eluting, right ventricular dual and single defibrillation coil leads with compatible pulse generators.