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 | IPAFLUOROFOCON A AND B |
Generic Name | Lens, contact (other material) - daily |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 N. GOODMAN ST. ROCHESTER, NY 14692 |
PMA Number | P860022 |
Supplement Number | S049 |
Date Received | 12/22/1997 |
Decision Date | 02/06/1998 |
Product Code |
HQD |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Wester Australia 60017. |
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