PMA P240003S003

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S003
Product code: PNF
Decision date: 2025-03-11
Classification: Cardiovascular
Generic name: Aortic stent
Approval order statement: Approval for quality controls in the manufacturing process that add a minimum fillet size specification and a maximum length specification to provide additional assurance of strength and reliability of the Minima Stent System.

Current openFDA PMA Record#

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S003
Product code: PNF
Generic name: Aortic stent
Decision date: 2025-03-11
Decision code: APPR
Date received: 2025-02-10
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for quality controls in the manufacturing process that add a minimum fillet size specification and a maximum length specification to provide additional assurance of strength and reliability of the Minima Stent System.