PMA P180003S005

Device: BioMimics 3D Vascular Stent System
Applicant: Veryan Medical, Ltd.
PMA number: P180003
Supplement: S005
Product code: NIP
Decision date: 2022-03-01
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for the addition of an alternative sterilization site located at Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, addition of a new sterilization cycle, an alternative load configuration and ability to perform endotoxin testing on non-sterile samples in the current laboratory.

Current openFDA PMA Record#

Device: BioMimics 3D Vascular Stent System
Applicant: Veryan Medical, Ltd.
PMA number: P180003
Supplement: S005
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2022-03-01
Decision code: APPR
Date received: 2021-10-14
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an alternative sterilization site located at Synergy Health Sterilization UK Ltd, STERIS AST Unit 1, Alpha Court, Capitol Park, Thorne, DN8 5TZ, United Kingdom, addition of a new sterilization cycle, an alternative load configuration and ability to perform endotoxin testing on non-sterile samples in the current laboratory.