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 | LL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | LOMBART LENSES, LTD. 1215 BOISSEVAIN AVE. NORFOLK, VA 23507 |
PMA Number | P840031 |
Supplement Number | S009 |
Date Received | 06/25/1998 |
Decision Date | 07/09/1998 |
Withdrawal Date
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11/07/2007 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators. |
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