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 | HYDROVIEW IOL BLANK MATERIAL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P990014 |
Supplement Number | S002 |
Date Received | 08/01/2002 |
Decision Date | 09/04/2002 |
Withdrawal Date
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10/11/2023 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TRANSFER OF THE LENS BLANK MATERIAL MANUFACTURING FACILITY TO BAUSCH & LOMB INC., WILMINGTON, MASSACHUSETTS. |
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