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 package insert (document number 9196252-001) that modified the percentage of patients who preferred high resolution sound processing to conventional sound processing. This modification is based on updated data received from patients at the 12-month follow-up visit which showed that three of the five patients who originally preferred their conventional strategy at the three-month experimental strategy visit switched their preference to hires. Thus, 48 of 50 patients (96%) ultimately preferred hires.
Device | CALRION CII BIONIC EAR SYSTEM (ADULT) |
Generic Name | Implant, Cochlear |
Applicant | ADVANCED BIONICS CORP. |
Date Received | 2002-10-25 |
Decision Date | 2002-11-06 |
PMA | P940022 |
Supplement | S027 |
Product Code | MCM |
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 |