SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER

Device, Angioplasty, Laser, Coronary

FDA Premarket Approval P870043 S014

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

DeviceSPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER
Classification NameDevice, Angioplasty, Laser, Coronary
Generic NameDevice, Angioplasty, Laser, Coronary
ApplicantTRIMEDYNE, INC.
Date Received1991-04-23
Decision Date1992-01-29
PMAP870043
SupplementS014
Product CodeLPC
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address TRIMEDYNE, INC. 25901 Commercentre Dr lake Forest, CA 92630

Supplemental Filings

Supplement NumberDateSupplement Type
P870043Original Filing
S016 1991-11-19 Normal 180 Day Track
S015 1991-08-29 Normal 180 Day Track
S014 1991-04-23 Normal 180 Day Track
S013 1990-12-06 Normal 180 Day Track
S012
S011 1990-04-30 Normal 180 Day Track
S010 1989-12-22 Normal 180 Day Track
S009 1989-10-26 Normal 180 Day Track
S008 1989-09-28 Normal 180 Day Track
S007 1989-02-03 Normal 180 Day Track
S006 1989-01-10 Normal 180 Day Track
S005 1988-12-27 Normal 180 Day Track
S004 1988-11-23 Normal 180 Day Track
S003 1988-11-03 Normal 180 Day Track
S002 1988-10-13 Normal 180 Day Track
S001 1988-09-14 Normal 180 Day Track

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