Allowing time for patient follow-up, Ortec expects to file a Pre-Market Approval Application
(PMA) with the FDA during the fourth quarter of this year.
Glaukos submitted a pre-market approval application
for the iStent inject to the FDA in December 2017.
In conjunction, the clinical study will be used to support the company's Pre-market Approval Application
(PMA) to market GelrinC in the US.
The request was submitted by Lifecore Biomedical, which was appealing a decision by CDRH that Lifecore's pre-market approval application
(PMA) for Intergel Adhesion Prevention Solution was not approvable."
CLOSURE Medical filed the pre-market approval application
(PMA) with the FDA in December 1996 whereupon the application was granted "expedited processing" because of the potential public health benefit of DERMABOND Topical Skin Adhesive to reduce patient pain and anxiety.
- US-based medical technology company Becton, Dickinson and Co (BD) (NYSE: BDX) has submitted a pre-market approval application
to the US Food and Drug Administration for the BD Onclarity HPV Assay, its human papillomavirus test, the company said on Tuesday.
- US-based Tryton Medical, Inc., a developer of stents designed to treat coronary bifurcation lesions, has filed the final module of its Pre-Market Approval application
with the US Food and Drug Administration for the Tryton Side Branch Stent, the company said on Monday.
has submitted to the Food and Drug Administration a Pre-Market Approval application
of its lead product the AspireAssist Aspiration Therapy System, an endoscopic alternative to weight loss surgery, the company said on Tuesday.
(NYSE: MDT) has submitted a pre-market approval application
to the US Food and Drug Administration for the use of its SynchroMed II implantable drug infusion system (including a newly developed catheter) for use with US-based United Therapeutics Corp.'s (NASDAQ: UTHR) Remodulin (treprostinil) Injection delivered intravenously to patients with pulmonary arterial hypertension, the company said on Wednesday.
The deadline for submitting pre-market approval applications
for POP repair with transvaginal mesh was July 5, 2018.