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 modified clarion device in which the implantable cochlear stimulator (ics) housing is made of zirconia instead of alumina. The new housing configuration is to be referred to as the cim 3.
| Device | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE |
| Applicant | ADVANCED BIONICS CORP. |
| Date Received | 1998-03-30 |
| Decision Date | 1998-05-28 |
| PMA | P940022 |
| Supplement | S005 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |