PMA_MER

Documents (2,258) JSON TSV

source DB	source ID	text	size	updated at	# proj.	# Ann.	updated_at
DevicePMAs@therightstef	P030035_S031	Approval for the model 3330 version6.1.1 software for the model 3650 merlin patient care system and model 3307 version 6.4.1 software for the model 3510 programmer which enables v-v timing, af suppres	538 Bytes	2020-03-03	11	28	-
DevicePMAs@therightstef	P980006_S007	Approval for adding a therapeutic indication for the purevision contact lens. The device, as modified, will be marketed under the trade name bausch & lomb purevision (balafilcon a) visibility tinted	1.29 KB	2020-03-03	11	51	-
DevicePMAs@therightstef	P910007_S004	Approval for the addition of a new intended use and is indicated for the quantitative measurement of Prostate Specific Antigen (PSA) in: 1) Human serum as an adjunctive test used as an aid in the mana	438 Bytes	2020-03-03	13	18	-
DevicePMAs@therightstef	P970008_S006	Approval for an expansion of the indication for use statement to include relief o obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to	356 Bytes	2020-03-03	13	20	-
DevicePMAs@therightstef	P040020_S050	Approval for the acrysof iq restor +2.5 d multifocal intraocular lens (iol), model sv25t0. this device is indicated for primary implantation in the capsular bag of the eye for the visual correction of	386 Bytes	2020-03-03	13	20	-
DevicePMAs@therightstef	P160002_S006	Approval for modifying the intended use of the VENTANA PD-L1(SP142). The VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 intended	1.29 KB	2020-03-03	13	54	-
DevicePMAs@therightstef	P960042_S000	Approval for the 12 French Laser Sheath Kit which consists of the 12 French Laser Sheath (Model 500-001) and Fish Tape accessory. The device is indicated for use as an adjunct to conventional lead ex	374 Bytes	2020-03-03	13	16	-
DevicePMAs@therightstef	P830045_S066	Approval is for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device is indicated for the programming and interrrogation of implanted St. Jude pacemak	204 Bytes	2020-03-03	13	6	-
DevicePMAs@therightstef	P830079_S014	Approval for removal of the neurological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade name instat absorbable collagen hemostat and is	482 Bytes	2020-03-03	11	14	-
DevicePMAs@therightstef	P950009_S004	Approval for use of the device with autocyte prep cervical cytology slides. The device, as modified, will be marketed under the trade name autopap primary screening system and is indicated for: the	1.1 KB	2020-03-03	13	49	-