SpaceOAR System - Radiotherapy protection spacer

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
21-04-2021

Saadav alates:

Boston Scientific Pty Ltd

Klass:

Class III

Valmistatud:

Boston Scientific Corporation 300 Boston Scientific Way, Marlborough, MA, 01752 United States Of America

Terapeutiline ala:

60424 - Radiotherapy protection spacer

Näidustused:

The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use. The hydrogel spacer maintains space for approximately 3 months and is absorbed in about 6 months, sufficient time to support the intended use. Intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum

Volitamisolek:

A

Loa andmise kuupäev:

2021-02-01

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