THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER

FDA Premarket Approval P870036 S044

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

Approval for a new product line. The device, as modified, will be marketed under the trade name medtronic(r) achiever(tm) coronary balloon dilatation catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

DeviceTHE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
Date Received1998-05-20
Decision Date1998-11-17
PMAP870036
SupplementS044
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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