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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 NameVARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP830060
Supplement NumberS067
Date Received03/28/2011
Decision Date09/01/2011
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 for design changes to the terminal tool (renamed ez-4 connector tool), design change to the lead and tool packaging, and various labeling changes.
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