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

Device. Laser Peripheral Angioplasty

FDA Premarket Approval P860042 S013

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

DeviceTRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Classification NameDevice. Laser Peripheral Angioplasty
Generic NameDevice. Laser Peripheral Angioplasty
ApplicantTRIMEDYNE, INC.
Date Received1989-01-10
Decision Date1989-07-20
PMAP860042
SupplementS013
Product CodeLWX
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.