Approval for adding the following language to the instructions for use (ifu): “intra-articular injection of sodium hyaluronate preparations has occasionally been associated with allergic/anaphylactic reactions and transient hypotension, which have generally resolved spontaneously or after conservative treatment. ”
| Device | MONOVISC |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2016-02-10 |
| Decision Date | 2016-02-25 |
| PMA | P090031 |
| Supplement | S006 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
Supplemental Filings
| 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 |
NIH GUDID Devices