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 | S050 |
Date Received | 02/20/1998 |
Decision Date | 03/31/1998 |
Product Code |
HQD |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the three additional finishing laboratories listed to become additional manufacturers and distributors of the device:Premier Contact Lens, 111 28th Avenue South, Nashville, TN 37212 and Premier Contact Lens, 3614 S.Perkins, Memphis, TN 38118. |
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