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 | Monovisc High Molecular Weight Hyaluronan |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 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 | P090031 |
| Supplement | S015 |
| 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 NumberP090031 Supplement NumberS015 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 |
|---|---|---|
| P090031 | Original Filing | |
| S015 | 2022-10-12 | 30-day Notice |
| S014 | 2022-10-03 | 30-day Notice |
| S013 | 2022-06-17 | 30-day Notice |
| S012 | 2021-09-15 | 30-day Notice |
| S011 | 2021-09-15 | 30-day Notice |
| S010 | 2021-08-11 | 30-day Notice |
| S009 | 2019-07-19 | Normal 180 Day Track |
| S008 | 2017-05-23 | Real-time Process |
| S007 | 2016-08-24 | 30-day Notice |
| S006 | 2016-02-10 | Special (immediate Track) |
| S005 | ||
| S004 | 2014-12-24 | 135 Review Track For 30-day Notice |
| S003 | 2014-11-07 | Real-time Process |
| S002 | 2014-06-10 | 30-day Notice |
| S001 | 2014-05-08 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05060548950033 | P090031 | 000 |
| 05060459970090 | P090031 | 000 |
| 08437027710018 | P090031 | 000 |