ApprovalTrail

Medical device licence · 83328 · Class 3

PROSTATE SEEDING KITS

Yes: licensed in Canada

Licence status Issued (active); first licensed July 9, 2010. It is in Health Canada’s list of active licences.
Licence number
83328
Licence holder
Theragenics CorporationBuford, GA, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
July 9, 2010
Devices covered
13

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • THERALOAD WITH I-SEED
  • THERALOAD WITH ONCOSEED
  • THERALOAD WITH THERASEED
  • THERALOAD WITH THINSEED
  • THERASLEEVE WITH I-SEED
  • THERASLEEVE WITH ONCOSEED
  • THERASLEEVE WITH THERASEED
  • THERASTRAND RT WITH AGX100 SEED
  • THERASTRAND RT WITH THERASEED
  • THERASTRAND WITH I-SEED
  • THERASTRAND WITH ONCOSEED
  • THERASTRAND WITH THERASEED
  • THERASTRAND WITH THINSEED

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.