FDA.reportPublic FDA data

Minima Stent System - 6mm

Primary DI
00196852801862
Brand
Minima Stent System - 6mm
Company
RENATA MEDICAL, INC.
Model
FG-0001
Device description
Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses.
Published
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
P240003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240003000Minima Stent SystemRenata Medical, Inc.2024-08-28PNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852801862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852801862001968528018621968528018620196852801862

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal aortic stentA non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084169964
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.PNF2025-04-02
00196852805037Minima Stent System - 8mmRENATA MEDICAL, INC.QWC2025-04-02
04046955766932G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
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04046955767076G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
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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
04046955767229G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07
04046955767236G-ARMOR STENT®B BRAUN INTERVENTIONAL SYSTEMS, INCPNF2022-05-07