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 | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM |
Generic Name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
Applicant | MERIDIAN AG BIERIGUTSTRAUSS 7 CH-3608 THUN, BE |
PMA Number | P840012 |
Supplement Number | S003 |
Date Received | 04/01/1987 |
Decision Date | 08/27/1987 |
Withdrawal Date
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09/15/2011 |
Product Code |
LOI |
Docket Number | 87M-0305 |
Notice Date | 10/19/1987 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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