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 | FINISHED METHAFILCON A CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | LOMBART LENSES, LTD. 1215 BOISSEVAIN AVE. NORFOLK, VA 23507 |
PMA Number | P890049 |
Supplement Number | S004 |
Date Received | 05/07/1998 |
Decision Date | 05/29/1998 |
Withdrawal Date
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11/13/2007 |
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 |
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