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 of a modified ics lead electrode, i. E. , the flex lead electrode.
| Device | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE |
| Applicant | ADVANCED BIONICS CORP. |
| Date Received | 1997-12-23 |
| Decision Date | 1998-03-17 |
| PMA | P940022 |
| Supplement | S004 |
| 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 |