Premarket Approval (PMA) | 合法醫療器材資訊網
References
Products Classification
Database information about MOZ
(www.accessdata.fda.gov)
NCT00653432
(www.clinicaltrials.gov)
PDF for P090031A
(www.accessdata.fda.gov)
PDF for P090031B
(www.accessdata.fda.gov)
PDF for P090031C
(www.accessdata.fda.gov)
PDF for P090031D
(www.accessdata.fda.gov)
S004
(www.accessdata.fda.gov)
S001
(www.accessdata.fda.gov)
S002
(www.accessdata.fda.gov)
S003
(www.accessdata.fda.gov)
S006
(www.accessdata.fda.gov)
S007
(www.accessdata.fda.gov)
S008
(www.accessdata.fda.gov)
S010
(www.accessdata.fda.gov)
...
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Admin info | 合法醫療器材資訊網
2014年2月25日 — The MONOVISC™ device is a proprietary high molecular weight hyaluronic acid ... anti-inflammatory drugs (NSAIDs), intra-articular injection of ... Read More
CLINICAL EFFICACY AND SAFETY OF MONOVISC® HIGH ... | 合法醫療器材資訊網
MONOVISC® HIGH MOLECULAR WEIGHT HYALURONAN ... Intra-articular hyaluronic acid (HA) injections have been used in the ... Device related AEs. 5.2%. Read More
FDA Approves MONOVISC® | 合法醫療器材資訊網
2014年2月25日 — ... mL intra-articular injection. Clinical Synopsis. The FDA approval of MONOVISC is based on safety and effectiveness data from a randomized, ... Read More
INFORMATION FOR PRESCRIBERS MONOVISC™ High ... | 合法醫療器材資訊網
2013年12月20日 — Federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner). ... the knee joint should inject Monovisc™ for the indicated use. ... within 48 hours following the intra-articular injection. Read More
Instructions for Use MONOVISC™ | 合法醫療器材資訊網
Federal law restricts this device to sale by or on the order of a physician (or ... Monovisc™ is indicated for the treatment of pain in osteoarthritis (OA) of the knee in ... Transient pain or swelling may occur after the intra-articular (IA) injection. Read More
Monovisc (High Molecular Weight Hyaluronan Injection) | 合法醫療器材資訊網
2018年2月28日 — The Monovisc™ device is a proprietary high molecular weight hyaluronic ... Standard intra-articular injection site preparation and precautions ... Read More
Monovisc (sodium hyaluronate) for the Treatment of ... | 合法醫療器材資訊網
The drug is available in a disposable glass syringe of 4.0ml dose that can be administered through intra-articular injection. Clinical trials on Monovisc. "FDA ... Read More
MONOVISC® | 合法醫療器材資訊網
As OA of the knee progresses, prescription medications such as NSAIDs, COX-2 Inhibitors and intraarticular corticosteroid injections may be appropriate next ... Read More
Premarket Approval (PMA) | 合法醫療器材資訊網
Single intra | 合法醫療器材資訊網
由 SC Petterson 著作 · 2019 · 被引用 13 次 — Conclusions: Monovisc™, a single-injection intra-articular HA device, is a safe and effective treatment for providing a clinically meaningful ... Read More
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