RGA6202 product code PDF

Preview

Summary

Product code...

Description

RGA 6202 HW #2 Due by Sunday, 12 May 2019 by 11:59 PM

Student Name: DRISHTI PATEL Instructions are to complete Table 2, convert to PDF file and submit under Week 5’s assignment tab. Table 1: Example of Completed Assignment Synvisc Device Name: Company Name:

Genzyme

sPMA number:

P940015/S034

PMA Supplement type: Date of approval: Brief description of change:

Real-Time Process

Link to letter on fda.gov:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P940015S034

24 Jul 2015 APPROVAL FOR THE FOLLOWING CHANGES FOR THE DELIVERY SYRINGES FOR SYNVISC® AND SYNVISC-ONE®:1) CHANGE OF THE CLEAR PLASTIC RIGID TIP CAP (PRTC) TO A BLUE PRTC;2) CHANGE OF THE CLEAR POLYSTYRENE PLUNGER ROD, WITH DIAMETERS OF 8.0 MM AND 13.4 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE POLYPROPYLENE PLUNGER ROD WITH DIAMETERS OF 8.2 MM AND 13.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 3) CHANGE OF THE THUMB PRESS ON THE PLUNGER ROD FROM A FLAT, SMOOTH SURFACE WITH DIAMETERS OF 12.7 MM AND 18.6 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A FLAT, TEXTURED SURFACE WITH DIAMETERS OF 19 MM AND 26.7 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 4) CHANGE OF THE GREY PROPYLENE OVAL-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 28.4 MM AND 43.8 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES, TO A BLUE PROPYLENE WING-SHAPED FINGER FLANGE, WITH OVERALL WIDTHS OF 35.6 MM AND 43.9 MM RESPECTIVELY FOR THE SYNVISC® AND SYNVISC-ONE® SYRINGES; 5) CHANGE OF THE TRANSPARENT SYRINGE LABEL TO A TRANSLUCENT SYRINGE LABEL WITH GRADED BLUE COLOR; AND6) CHANGE OF THE SYNVISC-ONE® BLISTER TRAY TO INCORPORATE A FINGER FLANGE CAVITY MODIFIED TO ACCOMMODATE THE NEW FLANGE DESIGN.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNVISC® AND SYNVISC-ONE® AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G. ACETAMINOPHEN.

RGA 6202 HW #2 Due by Sunday, 12 May 2019 by 11:59 PM

The Student Assignment is to complete this table using the example above. Table 2 ThermoCool SmartTouch Catheter Device Name: Company Name:

BIOSENSE WEBSTER, INC.

sPMA number:

P030031/S095

PMA Supplement type: Date of approval: Brief description of change:

Real-Time Process

Link to letter on fda.gov:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031S095

04/29/2019 Approval for a change to the user manuals of the SmartAblate Irrigation Pump and nGEN Pump to claim compatibility with the ThermoCool SmartTouch Catheter family....