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 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 |
Generic Name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
Applicant | COHERENT MEDICAL DIVISION 3270 WEST BAYSHORE RD. P.O. BOX 10122 PALO ALTO, CA 94303 |
PMA Number | P830054 |
Supplement Number | S012 |
Date Received | 09/08/1986 |
Decision Date | 10/16/1986 |
Product Code |
LOI |
Advisory Committee |
Ophthalmic |
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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