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 an alternate sterilization site located at griffith micro science, inc. , 5725 west harold gatty drive, salt lake city, utah 84116.
Device | CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) |
Generic Name | Implant, Cochlear |
Applicant | ADVANCED BIONICS CORP. |
Date Received | 1999-02-04 |
Decision Date | 1999-03-22 |
PMA | P940022 |
Supplement | S010 |
Product Code | MCM |
Advisory Committee | Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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 |