November 2021 : FA1197 Abre Venous Self-expanding Stent System IFU Update

FA1197 Abre Venous Self-expanding Stent System IFU Update

 

 

Affected Medical Device : Abre Venous Self-Expanding Stent System

 

MDA Reference Number : MDA/FCA/2021-P172

 

MDA Registration Number : GC3135420-42487

 

Description :

Instructions For Use (IFU) update to heightened awareness of migration in the venous stenting therapy space.

 

Local Establishment Contact Detail :

Athirah Abu Bakar
Regulatory Affairs Contingent
Medtronic
B-23-01, The Ascent, Paradigm
No. 1, Jalan SS7/26A,
47301 Petaling Jaya,
Selangor Darul Ehsan, Malaysia
Office +603-78838034 | Fax +603-78860474/4702

 

Email : [email protected]