ApprovalTrail

Medical device licence · 13038 · Class 3

700 PENILE PROSTHESIS

Yes: licensed in Canada

Licence status Issued (active); first licensed October 14, 1999. It is in Health Canada’s list of active licences.
Licence number
13038
Licence holder
Boston Scientific CorporationWatertown, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
October 14, 1999
Devices covered
41

Devices on this licence

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

  • 700 CX / CXM INFLATABLE PENILE PROSTHESIS
  • 700 CXR (NON-PRECONNECTED, NON-IZ) CYLINDERS
  • 700 CXR RTE PACKAGE
  • 700 ULTREX INFLATABLE PENILE PROSTHESIS
  • 700 ULTREX PLUS INFLATABLE PENILE PROSTHESIS
  • AMS 700 CX MS PUMP PRECONNECTED-PENOSCROTAL
  • AMS 700 CX MS PUMP PRECONNECTED-PENOSCROTAL INHIBIZONE
  • AMS 700 CX TENACIO PUMP PRECONNECTED - INFRAPUBIC
  • AMS 700 CX TENACIO PUMP PRECONNECTED - PENOSCROTAL
  • AMS 700 CX TENACIO PUMP, PRECONNECTED - INFRAPUBLIC INHIBIZONE
  • AMS 700 CX TENACIO PUMP, PRECONNECTED - PENOSCROTAL INHIBIZONE
  • AMS 700 CXR TENACIO PUMP, PRECONNECTED - INFRAPUBIC INHIBIZONE
  • AMS 700 CXR TENACIO PUMP, PRECONNECTED - PENOSCROTAL INHIBIZONE
  • AMS 700 LGX MS PUMP PRECONNECTED-PENOSCROTAL
  • AMS 700 LGX MS PUMP PRECONNECTED-PENOSCROTAL INHIBIZONE
  • AMS 700 LGX TENACIO PUMP PRECONNECTED - INFRAPUBIC
  • AMS 700 LGX TENACIO PUMP PRECONNECTED - PENOSCROTAL
  • AMS 700 LGX TENACIO PUMP, PRECONNECTED - INFRAPUBIC INHIBIZONE
  • AMS 700 LGX TENACIO PUMP, PRECONNECTED - PENOSCROTAL INHIBIZONE
  • AMS 700 TENACIO PUMP
  • AMS 700 TENACIO PUMP INHIBIZONE
  • AMS 700 WITH TENACIO PUMP ACCESSORY KIT
  • CX PRECONNECT WITH MS PUMP, INFRAPUBIC
  • CX PRECONNECT WITH MS PUMP, INFRAPUBIC INHIBIZONE COATED
  • CX PRECONNECT WITH MS PUMP, PENOSCROTAL
  • CX PRECONNECT WITH MS PUMP, PENOSCROTAL INHIBIZONE COATED
  • CX SNAP FIT WITH RT CYLINDERS
  • CX SNAP FIT WITH RT INHIBIZONE COATED CYLINDER
  • CXR PRECONNECT WITH MS PUMP, INFRAPUBIC INHIBIZONE COATED
  • CXR PRECONNECT WITH MS PUMP, PENOSCROTAL INHIBIZONE COATED
  • LGX PRECONNECT WITH MS PUMP, INFRAPUBIC
  • LGX PRECONNECT WITH MS PUMP, INFRAPUBIC INHIBIZONE COATED
  • LGX PRECONNECT WITH MS PUMP, PENOSCROTAL
  • LGX PRECONNECT WITH MS PUMP, PENOSCROTAL INHIBIZONE COATED
  • LGX SNAP FIT WITH RT CYLINDERS
  • LGX SNAP FIT WITH RT INHIBIZONE COATED CYLINDER
  • PUMP MS
  • PUMP MS INHIBIZONE COATED
  • RESERVOIR, PC
  • RESERVOIR, PC INHIBIZONE COATED
  • SNAP FIT RTE

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