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 the following changes to the postmarket study protocol: 1) use of only the pb-k test to determine candidacy in children 4 years through 17 years of age at time of implant. 2) substitution of the pb-k test for the esp test as an outcome measure. 3) division of the youngest age group into two groups. 4) additional inclusion/exclusion criteria for adults and children.
Device | CLARION CII BIONIC EAR SYSTEM (ADULT) |
Generic Name | Implant, Cochlear |
Applicant | ADVANCED BIONICS CORP. |
Date Received | 2002-10-25 |
Decision Date | 2002-11-01 |
PMA | P940022 |
Supplement | S026 |
Product Code | MCM |
Advisory Committee | Ear Nose & Throat |
Supplement Type | Real-time Process |
Supplement Reason | Other Report |
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 |