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 | 8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER |
Generic Name | DEVICE, ANGIOPLASTY, LASER, CORONARY |
Applicant | TRIMEDYNE, INC. 25901 COMMERCENTRE DR LAKE FOREST, CA 92630 |
PMA Number | P870043 |
Supplement Number | S003 |
Date Received | 11/03/1988 |
Decision Date | 04/19/1989 |
Withdrawal Date
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08/08/2012 |
Product Code |
LPC |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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