TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Device. Laser Peripheral Angioplasty

FDA Premarket Approval P860042

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceTRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Classification NameDevice. Laser Peripheral Angioplasty
Generic NameDevice. Laser Peripheral Angioplasty
ApplicantTRIMEDYNE, INC.
Date Received1986-09-02
Decision Date1987-02-27
Notice Date1987-04-06
PMAP860042
SupplementS
Product CodeLWX
Docket Number87M-0076
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address TRIMEDYNE, INC. 25901 Commercentre Dr lake Forest, CA 92630

Supplemental Filings

Supplement NumberDateSupplement Type
P860042Original Filing
S027 1993-05-17 Normal 180 Day Track
S026 1991-11-19 Normal 180 Day Track
S025 1990-10-23 Normal 180 Day Track
S024 1989-12-22 Normal 180 Day Track
S023 1989-11-24 Normal 180 Day Track
S022 1989-09-06 Normal 180 Day Track
S021 1989-08-11 Normal 180 Day Track
S020 1989-07-31 Normal 180 Day Track
S019 1989-04-14 Normal 180 Day Track
S018
S017 1989-02-03 Normal 180 Day Track
S016 1989-01-27 Normal 180 Day Track
S015 1989-01-19 Normal 180 Day Track
S014 1989-01-10 Normal 180 Day Track
S013 1989-01-10 Normal 180 Day Track
S012 1988-12-27 Normal 180 Day Track
S011 1988-12-22 Normal 180 Day Track
S010 1988-12-02 Normal 180 Day Track
S009 1988-11-03 Normal 180 Day Track
S008 1988-10-21 Normal 180 Day Track
S007 1988-10-07 Normal 180 Day Track
S006 1988-09-29 Normal 180 Day Track
S005 1988-08-02 Normal 180 Day Track
S004 1987-12-16 Normal 180 Day Track
S003 1987-06-23 Normal 180 Day Track
S002 1987-04-28 Normal 180 Day Track
S001 1987-04-28 Normal 180 Day Track

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