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 a revision to the information guide in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following questioin and answer has been afixed to page 29: "are there any restrictions on physical activities with clarion? " "clarion is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, sucha s using a protective helmet to reduce the risk of device failure. "
| Device | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE |
| Applicant | ADVANCED BIONICS CORP. |
| Date Received | 1998-06-30 |
| Decision Date | 1998-09-04 |
| PMA | P940022 |
| Supplement | S006 |
| 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 |