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 | CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S010 |
Date Received | 02/04/1999 |
Decision Date | 03/22/1999 |
APCB Date
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10/18/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization site located at Griffith Micro Science, Inc., 5725 West Harold Gatty Drive, Salt Lake City, Utah 84116. |
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