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 modifications to the device fitting software for adults and pediatrics. The device, as modified, will be marketed under the trade name clarion multi-strategy cochlear implant (adult) and (pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.
| Device | CLARION DEVICE FITTING SOFTWARE (SCLIN) |
| Generic Name | Implant, Cochlear |
| Applicant | ADVANCED BIONICS CORP. |
| Date Received | 1999-03-24 |
| Decision Date | 1999-07-16 |
| PMA | P940022 |
| Supplement | S011 |
| Product Code | MCM |
| 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 |