PMA P240003S006

Device: Minima Pro Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S006
Product code: PNF
Decision date: 2026-07-09
Classification: Cardiovascular
Generic name: Aortic stent
Approval order statement: Approval for design modifications and a line extension to the Minima Stent System, including a stent design change from closed cell to hybrid open-cell, a new 10mm balloon size for expansion of the stent, delivery system design changes, and packaging design changes. The device, as modified, will be marketed under the trade name Minima Pro Stent System.

Current openFDA PMA Record#

Device: Minima Pro Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S006
Product code: PNF
Generic name: Aortic stent
Decision date: 2026-07-09
Decision code: APPR
Date received: 2025-12-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design modifications and a line extension to the Minima Stent System, including a stent design change from closed cell to hybrid open-cell, a new 10mm balloon size for expansion of the stent, delivery system design changes, and packaging design changes. The device, as modified, will be marketed under the trade name Minima Pro Stent System.