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 | MENICON SF-P (MELAFOCON A) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | MENICON CO. LTD. 269A BALLARDVALE ST. WILMINGTON, MA 01887 |
PMA Number | P880098 |
Supplement Number | S008 |
Date Received | 05/15/1995 |
Decision Date | 06/23/1995 |
Withdrawal Date
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05/05/2008 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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