|
Device | BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A) |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 N. GOODMAN ST. ROCHESTER, NY 14692 |
PMA Number | P860022 |
Supplement Number | S056 |
Date Received | 01/27/2006 |
Decision Date | 05/30/2006 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS |