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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACUITY SPIRAL LEAD FAMILY
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS260
Date Received11/26/2010
Decision Date08/05/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING CHANGES: 1) ADD AN ALTERNATE DEXAMETHASONE ACETATE SUPPLIER; 2) UPDATE TO DXA MIXING PROCESS PARAMETERS TO ENHANCE PROCESS CAPABILITY; 3) ALTERNATE ANALYTICAL METHOD TO TEST FOR DOSAGE AND PRODUCT DEGRADATION; 4) MODIFICATION OF THE ANALYTICAL METHODS TO REMOVE IMPURITY PEAKS OBSERVED; AND 5) ADD IN PROCESS VERIFICATION FOR MIX HOMOGENEITY.
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