ApprovalTrail

Medical device licence · 14526 · Class 3

SCLERAL BUCKLING COMPONENTS

No longer licensed: cancelled: quality-system requirement (2003)

Licence status Cancelled: quality-system requirement (2003); first licensed November 25, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
Licence number
14526
Licence holder
Mira Inc.Uxbridge, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 25, 1999
Ended
February 16, 2004
Devices covered
3

Devices on this licence

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

  • SCLERAL BUCKLING COMPONENTS - TANTALUM CLIPS
  • SILICONE SCLERAL BUCKLING IMPLANTS - SOLID
  • SILICONE SCLERAL BUCKLING IMPLANTS - SPONGES

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