FDA.reportPublic FDA data

Minima Pro Stent System - 6mm

Primary DI
00850075943005
Brand
Minima Pro Stent System - 6mm
Company
RENATA MEDICAL, INC.
Model
FG-0009
Device description
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
Published
2026-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PNFAortic Stent
QWCPulmonary Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNFAortic StentUnknown3
QWCPulmonary StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240003006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240003006Minima Stent System and Minima Pro Stent SystemRenata Medical, Inc.2024-08-28PNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850075943005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850075943005008500759430058500759430050850075943005

Regulatory Flags#

DUNS number
084169964
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196852801862Minima Stent System - 6mmFG-00012025-04-02
00196852805037Minima Stent System - 8mmFG-00022025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20705032101186PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101193PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101209PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101216PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
20705032101223PALMAZ MULLINS XD Pulmonary StentCordis US Corp.QWC2025-05-31
00196852801862Minima Stent System - 6mmRENATA MEDICAL, INC.PNF2025-04-02
00196852801862Minima Stent System - 6mmRENATA MEDICAL, INC.QWC2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.QWC2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.PNF2025-04-02
04046955766932G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955766949G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767038G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767045G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767052G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767069G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767076G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767083G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767090G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767106G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767113G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767120G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767137G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767144G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767151G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767168G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767175G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767182G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767199G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767205G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767212G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07