PMA P240003S001

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S001
Product code: PNF
Decision date: 2024-11-08
Classification: Cardiovascular
Generic name: Aortic stent
Approval order statement: Approval for the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240003.

Current openFDA PMA Record#

Device: Minima Stent System
Applicant: Renata Medical, Inc.
PMA number: P240003
Supplement: S001
Product code: PNF
Generic name: Aortic stent
Decision date: 2024-11-08
Decision code: APPR
Date received: 2024-09-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240003.