Note: 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. |
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Device | SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | TRIMEDYNE, INC. 25901 COMMERCENTRE DR LAKE FOREST, CA 92630 |
PMA Number | P870043 |
Supplement Number | S014 |
Date Received | 04/23/1991 |
Decision Date | 01/29/1992 |
Withdrawal Date
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08/08/2012 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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