META DDDR PACING SYSTEM

Implantable Pacemaker Pulse-generator

FDA Premarket Approval P900070 S004

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.

Pre-market Approval Supplement Details

DeviceMETA DDDR PACING SYSTEM
Classification NameImplantable Pacemaker Pulse-generator
Generic NameImplantable Pacemaker Pulse-generator
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
Date Received1993-01-27
Decision Date1993-04-21
PMAP900070
SupplementS004
Product CodeDXY
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P900070Original Filing
S034 2006-06-07 Real-time Process
S033
S032 2006-03-30 Real-time Process
S031 2006-02-22 Normal 180 Day Track
S030 2006-02-16 Normal 180 Day Track
S029
S028 2002-12-24 Real-time Process
S027 2000-08-11 Normal 180 Day Track
S026 2000-01-31 30-day Notice
S025 1999-09-07 Real-time Process
S024 1998-10-06 Real-time Process
S023 1998-09-09 30-day Notice
S022 1998-03-06 Normal 180 Day Track
S021 1997-09-29 Normal 180 Day Track
S020 1997-09-10 Real-time Process
S019 1997-04-14 Normal 180 Day Track
S018 1997-04-08 Normal 180 Day Track
S017 1997-02-26 Normal 180 Day Track
S016 1997-02-11 Normal 180 Day Track
S015 1996-11-06 Normal 180 Day Track
S014 1996-09-16 Normal 180 Day Track
S013
S012 1995-12-07 Normal 180 Day Track
S011 1995-02-06 Normal 180 Day Track
S010 1995-01-18 Normal 180 Day Track
S009 1994-07-29 Normal 180 Day Track
S008
S007 1993-11-08 Normal 180 Day Track
S006 1993-07-01 Normal 180 Day Track
S005 1993-06-17 Normal 180 Day Track
S004 1993-01-27 Normal 180 Day Track
S003 1992-10-05 Normal 180 Day Track
S002 1992-06-19 Normal 180 Day Track
S001 1992-06-15 Normal 180 Day Track

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