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 to revise the professional fitting and information guide product labeling to include fitting guidelines for corneal topography-based fitting methods and other minor changes and grammatical corrections. The device, as modified, will be marketed under the trade name referenced above with the same prior approved indications for use.
| Device | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | BAUSCH & LOMB |
| Date Received | 2004-09-01 |
| Decision Date | 2004-12-03 |
| PMA | P010062 |
| Supplement | S002 |
| Product Code | NUU |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| 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 |