MAESTRO SERIES 500 P.G. MODELS 501, 505, 509

FDA Premarket Approval P860027 S002

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

DeviceMAESTRO SERIES 500 P.G. MODELS 501, 505, 509
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantCARDIAC CONTROL SYSTEMS, INC.
Date Received1988-02-17
Decision Date1988-12-28
PMAP860027
SupplementS002
Product CodeLWP 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARDIAC CONTROL SYSTEMS, INC. 3 Commerce Blvd. palm Coast, FL 32164

Supplemental Filings

Supplement NumberDateSupplement Type
P860027Original Filing
S012 1997-06-12 Real-time Process
S011 1995-12-26 Normal 180 Day Track
S010 1995-03-01 Normal 180 Day Track
S009 1992-07-10 Normal 180 Day Track
S008 1991-01-04 Normal 180 Day Track
S007 1990-11-08 Normal 180 Day Track
S006 1990-11-01 Normal 180 Day Track
S005 1990-04-19 Normal 180 Day Track
S004 1990-03-20 Normal 180 Day Track
S003 1988-09-23 Normal 180 Day Track
S002 1988-02-17 Normal 180 Day Track
S001 1987-10-14 Normal 180 Day Track

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