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 wet shipping, with storage up to 30 days, of the boston equalens, equalens ii and boston orthokeratology shaping rigid gas permeable contact lenses in boston simplus multi-action solution.
| Device | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | BAUSCH & LOMB |
| Date Received | 2008-01-31 |
| Decision Date | 2008-02-21 |
| PMA | P010062 |
| Supplement | S006 |
| Product Code | NUU |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 1400 North Goodman St. rochester, NY 14603-0450 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010062 | Original Filing | |
| S011 | 2018-05-25 | Real-time Process |
| S010 | 2016-06-27 | 30-day Notice |
| S009 | 2011-05-31 | 30-day Notice |
| S008 | 2010-10-20 | Normal 180 Day Track No User Fee |
| S007 | 2009-10-13 | Normal 180 Day Track No User Fee |
| S006 | 2008-01-31 | Real-time Process |
| S005 | 2006-12-21 | Real-time Process |
| S004 | 2006-01-27 | 135 Review Track For 30-day Notice |
| S003 | 2005-04-18 | Normal 180 Day Track No User Fee |
| S002 | 2004-09-01 | Real-time Process |
| S001 | 2004-07-06 | Real-time Process |