Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - Stratafix™ Spiral PGA-PCL Knotless Tissue Control Device - Suture,
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd
PO Box 134,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Angiotech Puerto Rico Inc
Road 459 KM 0.6 Montana Industrial Park
Aguadilla, , 00603
1. Stratafix™ Spiral PGA-PCL Knotless Tissue Control Device - Suture, poliglecaprone
Single Device Product
45814 Suture, poliglecaprone
Stratafix™ Spiral PGA-PCL Knotless Tissue Control Device is an absorbable, bidirectional-barbed
monofilament suture armed with a surgical needle on each end for tissue insertion. The barbs are arrayed
in opposing directions on either side of a transitional, nonbarbed segment. The device is advanced into the
tissue, via surgical needles attached to each end, until the opposing barbs are engaged. The barbs
penetrate into the surrounding tissue and lock the device in place.
Stratafix™ Spiral PGA-PCL is indicated for use in soft tissue approximation where use of absorbable
sutures is appropriate.
Length (cm) 7x7
Length (cm) 14x14
Length (cm) 16x16
Length (cm) 30x30
Length (cm) 36x36
Suture, needle, physical attributes 1/2 circle
Suture, needle, physical attributes 3/8 circle
Suture, needle, physical attributes Diamond Point
Suture, needle, physical attributes Taper Point
Suture, needle, physical attributes Reverse Cutting
Suture, gauge Length(mm): 18 to 36
Suture, gauge 3.5 to 2 (metric)
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 04:33:24 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information