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 | S004 |
Date Received | 07/08/1997 |
Decision Date | 12/24/1997 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Requested that a Phase IV trial of AdatoSil 5000(TM) no longer be required as a condition of approval for this PMA, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of AdatoSil 5000(TM) silicone oil. |
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