MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER

FDA Premarket Approval P870036 S019

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

DeviceMEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
Date Received1992-09-16
Decision Date1993-04-28
PMAP870036
SupplementS019
Product CodeLOX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONICS INTERVENTIONAL VASCULAR 3576 Uno Cal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P870036Original Filing
S044 1998-05-20 Normal 180 Day Track
S043 1997-03-03 Normal 180 Day Track
S042 1997-01-29
S041 1996-11-21 Normal 180 Day Track
S040 1996-09-19 Special (immediate Track)
S039 1996-06-24 Normal 180 Day Track
S038 1996-04-16 Normal 180 Day Track
S037 1995-11-01 Normal 180 Day Track
S036 1995-07-17 Normal 180 Day Track
S035 1995-04-07 30-Day Supplement
S034 1995-01-31 Normal 180 Day Track
S033
S032 1994-10-17 Normal 180 Day Track
S031 1994-06-27 Normal 180 Day Track
S030 1994-03-09 Normal 180 Day Track
S029 1994-03-03 Normal 180 Day Track
S028 1994-01-24 Normal 180 Day Track
S027 1993-07-30 Normal 180 Day Track
S026 1993-03-29 Normal 180 Day Track
S025 1993-03-01 Normal 180 Day Track
S024 1993-02-01 Normal 180 Day Track
S023 1993-01-05 Normal 180 Day Track
S022
S021 1992-11-16 Normal 180 Day Track
S020 1992-10-07 Normal 180 Day Track
S019 1992-09-16 Normal 180 Day Track
S018 1992-05-26 Normal 180 Day Track
S017 1992-02-11 Normal 180 Day Track
S016
S015 1991-11-21 Normal 180 Day Track
S014 1991-09-12 Normal 180 Day Track
S013 1991-08-29 Normal 180 Day Track
S012 1991-08-23 Normal 180 Day Track
S011 1991-02-08 Normal 180 Day Track
S010 1990-12-14 Normal 180 Day Track
S009 1990-11-08 Normal 180 Day Track
S008 1990-08-08 Normal 180 Day Track
S007 1989-11-03 Normal 180 Day Track
S006 1989-08-21 Normal 180 Day Track
S005 1989-04-20 Normal 180 Day Track
S004 1989-03-03 Normal 180 Day Track
S003 1989-02-21 Normal 180 Day Track
S002 1989-02-17 Normal 180 Day Track
S001 1988-04-12 Normal 180 Day Track

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