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 Contol Device is an absorbable, unidirectional barbed
monofilament suture armed with a surgical needle at one end, and a Variable Loop Design at the opposite
end to preclude the use of a knot to secure tissue.
Stratafix Spiral PGA-PCL Knotless Tissue Control Device is indicated for use in soft tissue approximation
where the use of absorbable sutures is appropriate.
Suture, needle, physical attributes Length (mm): 17
Length (cm) 20 to 60
Suture, needle, physical attributes Taper Point
Suture, needle, physical attributes Precision Point
Suture, needle, physical attributes 1/2 circle
Suture, needle, physical attributes 3/8 circle
Suture, gauge 2 to 4 (metric)
No Specific Conditions included on Record
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