Summary for ARTG Entry:
The Critical Group Pty Ltd - Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture,
ARTG entry for
Medical Device Included Class III
The Critical Group Pty Ltd
PO Box 6466,BAULKHAM HILLS BUSINESS CENTRE, NSW, 2153
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. Quill PDO Knotless Tissue Closure Device (Polydioxone) - Suture, polydioxanone
Single Device Product
16584 Suture, polydioxanone
The Quill PDO knotless tissue closure device of dyed PDO absorbable surgical suture material consists of
barbed suture material, armed with a surgical needle on each end. The barbs allow for tissue
approximation without the need to tie surgical knots.
The Quill PDO are absorbable synthetic surgical suture intended for use in general soft tissue
approximation but not cardiovascular and neurological procedures, microsurgery or ophthalmic
Suture, gauge 0 - 4.0 USP Diameter
Length (cm) 7 x 7 (Barb Length)
Length (cm) 3.5 x 3.5 (Barb Length)
Length (cm) 10 x 10 (Barb Length)
Length (cm) 14 x 14 (Barb Length)
Length (cm) 24 x 24 (Barb Length)
Length (cm) 30 x 30 (Barb Length)
Length (cm) 36 x 36 (Barb Length)
Length (cm) 40 x 40 (Barb Length)
Length (cm) 45 x 45 (Barb Length)
Shape (of tip) Taper 1/2 Circle
Shape (of tip) Diamond 1/2 Circle
Shape (of tip) Diamond 3/8 Circle
Length (cm) Reverse Cutting - 1/2 Circle
Shape (of tip) Taper Cutting - Straight
Shape (of tip) Taper - Straight
Length (mm) 12 - 50
No Specific Conditions included on Record
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