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 | ADATO SIL 5000 |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910071 |
Supplement Number | S001 |
Date Received | 11/18/1994 |
Decision Date | 11/30/1994 |
Product Code |
LWL |
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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