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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDELTA PACEMAKER SYS; VIGOR DDD MODEL 950
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generators & programmers
ApplicantBOSTON SCIENTIFIC
PMA NumberP840068
Date Received12/21/1984
Decision Date11/27/1985
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 85M-0579
Notice Date 01/24/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S046 
S047 S048 S049 S050 S051 S052 S053 
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