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.
Approval for changing the product name of the hires software, model number ci-6055. The software will be marketed under the trade name soundwave professional suite, model number ci-6055, and is indicated for use in adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12 months to 17 years, 11-months of age).
Device | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT |
Generic Name | Implant, Cochlear |
Applicant | ADVANCED BIONICS CORP. |
Date Received | 2002-09-19 |
Decision Date | 2002-09-23 |
PMA | P940022 |
Supplement | S025 |
Product Code | MCM |
Advisory Committee | Ear Nose & Throat |
Supplement Type | Real-time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | ADVANCED BIONICS CORP. 12740 San Fernando Rd. sylmar, CA 91342 |
Supplement Number | Date | Supplement Type |
---|---|---|
P940022 | Original Filing | |
S027 | 2002-10-25 | Real-time Process |
S026 | 2002-10-25 | Real-time Process |
S025 | 2002-09-19 | Real-time Process |
S024 | 2002-09-16 | Real-time Process |
S023 | 2002-07-29 | Normal 180 Day Track |
S022 | 2002-05-28 | Real-time Process |
S021 | 2002-05-28 | Real-time Process |
S020 | 2002-04-12 | Real-time Process |
S019 | ||
S018 | ||
S017 | ||
S016 | 2000-11-16 | Normal 180 Day Track |
S015 | 2000-05-10 | Normal 180 Day Track |
S014 | 2000-03-22 | Normal 180 Day Track |
S013 | 1999-11-12 | Normal 180 Day Track |
S012 | 1999-09-30 | Normal 180 Day Track |
S011 | 1999-03-24 | Normal 180 Day Track |
S010 | 1999-02-04 | Normal 180 Day Track |
S009 | ||
S008 | 1998-09-03 | Normal 180 Day Track |
S007 | 1998-08-24 | Normal 180 Day Track |
S006 | 1998-06-30 | Real-time Process |
S005 | 1998-03-30 | Normal 180 Day Track |
S004 | 1997-12-23 | Normal 180 Day Track |
S003 | 1997-07-10 | Normal 180 Day Track |
S002 | 1996-11-15 | Normal 180 Day Track |
S001 | 1996-04-05 | Normal 180 Day Track |