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.
Device | Orthovisc, Sodium Hyaluronic |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-10-12 |
Decision Date | 2022-11-08 |
PMA | P030019 |
Supplement | S027 |
Product Code | MOZ |
Advisory Committee | Orthopedic |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of An Alternate Supplier Of Fermented Hyaluronic Acid (HA) Raw Material For Orthovisc And Monovisc |
Supplement Number | Date | Supplement Type |
---|---|---|
P030019 | Original Filing | |
S027 | 2022-10-12 | 30-day Notice |
S026 | 2020-12-30 | 135 Review Track For 30-day Notice |
S025 | 2020-11-09 | 30-day Notice |
S024 | ||
S023 | 2016-02-10 | Special (immediate Track) |
S022 | 2014-12-24 | 135 Review Track For 30-day Notice |
S021 | 2014-06-25 | 30-day Notice |
S020 | 2014-06-10 | 30-day Notice |
S019 | 2014-05-15 | 30-day Notice |
S018 | 2011-08-24 | 135 Review Track For 30-day Notice |
S017 | 2010-11-03 | 135 Review Track For 30-day Notice |
S016 | ||
S015 | 2010-06-09 | 30-day Notice |
S014 | 2009-06-16 | Normal 180 Day Track No User Fee |
S013 | 2006-07-24 | 135 Review Track For 30-day Notice |
S012 | 2006-08-09 | Normal 180 Day Track |
S011 | ||
S010 | 2006-07-10 | 30-day Notice |
S009 | 2006-04-28 | Normal 180 Day Track |
S008 | 2006-01-03 | 30-day Notice |
S007 | ||
S006 | 2004-07-01 | Normal 180 Day Track |
S005 | 2004-06-17 | 30-day Notice |
S004 | 2004-05-07 | 30-day Notice |
S003 | 2004-03-16 | 30-day Notice |
S002 | ||
S001 | 2004-02-27 | 135 Review Track For 30-day Notice |
Device ID | PMA | Supp |
---|---|---|
05060548950026 | P030019 | 000 |
08437027710025 | P030019 | 000 |
05060459970038 | P030019 | 022 |
00817337000111 | P030019 | 026 |