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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 NameACUITY STEERABLE IS-1 LEADS
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP050046
Supplement NumberS012
Date Received01/19/2012
Decision Date03/05/2012
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following changes: 1) addition of optinova as supplier of extruded polyurethane tubing; 2) modification to dimensional tolerances for extruded polyurethane tubing; 3) modification to polyurethane tubing specification for foreign material, bubbles, and gel inclusions; and 4) removal of redundant methylene dianiline (mda) residual level requirements for extruded tubing.
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