FDA.reportPublic FDA data

CardioMEMS™

Primary DI
05414734510257
Brand
CardioMEMS™
Company
ST. JUDE MEDICAL, INC.
Model
CM3026
Catalog number
CM3026
Device description
Power Cord Clip
Published
2023-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MOMSystem, hemodynamic, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOMSystem, Hemodynamic, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100045000CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMABBOTT MEDICAL2014-05-28MOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734510257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734510257054147345102575414734510257

GMDN Terms#

Term, Definition table
TermDefinition
Implantable pulmonary artery pressure monitoring systemAn assembly of devices intended for regular (e.g., daily) measurement and recording of pulmonary artery pressures, to assist monitoring and treatment of a heart disease patient at high-risk of heart failure. It includes a sensor intended to be implanted in the pulmonary artery, an external monitoring system(s), information software, and typically devices associated with implantation. The monitoring system(s) are intended to wirelessly power and interrogate the implanted sensor via an antenna, and display/record/communicate arterial blood pressure information (e.g., systolic, diastolic and mean pressures, heart rate). It is intended for monitoring in both the home and healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067055811EnSite™ENSITE-SW-6.1ENSITE-SW-6.12026-06-01
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067047014CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047021CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047038CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067047045CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067048325CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067049612CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
05415067054838CardioMEMS™CARDIOMEMS, INC.MOM2026-03-13
00850008997143myCordella Handheld Patient Reader AlloyEndotronix, Inc.MOM2025-10-13
00850008997006Cordella Sensor Delivery KitEndotronix, Inc.MOM2024-08-14
00850008997013myCordella Handheld Patient ReaderEndotronix, Inc.MOM2024-08-13
00850008997020Cordella Calibration EquipmentEndotronix, Inc.MOM2024-08-13
00850008997051Cordella Data Analysis PlatformEndotronix, Inc.MOM2024-08-13
05414734509206CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-22
05414734509220CardioMEMS™CARDIOMEMS, INC.MOM2023-06-22
05414734509268CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-22
05414734509183CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509190CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509213CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509251CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509275CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509282CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509299CardioMEMS™CARDIOMEMS, INC.MOM2023-06-21
05414734509312CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509398CardioMEMS™CARDIOMEMS, INC.MOM2023-06-21
05414734509909CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509916CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509923CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05414734509978CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05415067034724CardioMEMS™CARDIOMEMS, INC.MOM2022-04-27
05415067034731CardioMEMS™CARDIOMEMS, INC.MOM2022-04-27