PMA P240003S005

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S005
Product code: PNF
Decision date: 2025-12-18
Classification: Cardiovascular
Generic name: Aortic stent
Approval order statement: to move the dimensional inspection of the Minima Stent from a receiving step at the system assembly contract manufacturer, Medical Murray, to an outgoing inspection at the Minima Stent Manufacturer, Meko Laser

Current openFDA PMA Record#

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S005
Product code: PNF
Generic name: Aortic stent
Decision date: 2025-12-18
Decision code: OK30
Date received: 2025-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to move the dimensional inspection of the Minima Stent from a receiving step at the system assembly contract manufacturer, Medical Murray, to an outgoing inspection at the Minima Stent Manufacturer, Meko Laser