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.
Approval for manufacture, market and distribute overnight orthokeratology contact lenses from the menicon z™ (tisilfocon a) rigid gas permeable contact lens material, which is fda approved for extended wear under p990018
Device | Menicon Z Night (tisilfocon A) COntact Lenses for Overnight Wear |
Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
Applicant | MENICON CO. LTD. |
Date Received | 2018-11-28 |
Decision Date | 2019-11-06 |
PMA | P990018 |
Supplement | S005 |
Product Code | MWL |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | MENICON CO. LTD. 269 A Ballardvale Street wilmington, MA 01887 |
Supplement Number | Date | Supplement Type |
---|---|---|
P990018 | Original Filing | |
S008 | 2022-02-07 | Normal 180 Day Track |
S007 | ||
S006 | 2021-01-21 | Normal 180 Day Track No User Fee |
S005 | 2018-11-28 | Normal 180 Day Track |
S004 | 2009-04-01 | Normal 180 Day Track No User Fee |
S003 | 2002-10-21 | Real-time Process |
S002 | 2001-11-28 | Panel Track |
S001 | 2000-07-28 | Normal 180 Day Track |