Note: 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. |
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Device | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. ROCHESTER, NY 14603-0450 |
PMA Number | P010062 |
Supplement Number | S010 |
Date Received | 06/27/2016 |
Decision Date | 07/25/2016 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternate supplier of a critical raw material component. |
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