| 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 | ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER |
| Generic Name | intraocular lens |
| Regulation Number | 886.3600 |
| Applicant | Bausch & Lomb, Inc. 50 Technology Dr. Irvine, CA 92618 |
| PMA Number | P880090 |
| Supplement Number | S016 |
| Date Received | 11/21/1994 |
| Decision Date | 02/08/1995 |
| Product Code |
HQL |
| Advisory Committee |
Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/Components/Specifications/Material |
| Expedited Review Granted? | No |
| Combination Product | No |
| Predetermined Change Control Plan Authorized | No |
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