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 a labeling update to the package insert and patient information booklet to include the results from a section 522 postmarket surveillance study (pas).
| Device | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | BAUSCH & LOMB |
| Date Received | 2010-10-20 |
| Decision Date | 2014-07-28 |
| PMA | P010062 |
| Supplement | S008 |
| Product Code | NUU |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |