FDA.reportPublic FDA data

CardioMEMS™

Primary DI
05415067034724
Brand
CardioMEMS™
Company
CARDIOMEMS, INC.
Model
CM3100
Catalog number
CM3100
Device description
Hospital System
Published
2022-04-27
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
P100045049
P100045059

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100045049CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMABBOTT MEDICAL2014-05-28MOM
P100045059CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEMABBOTT MEDICAL2014-05-28MOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067034724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067034724054150670347245415067034724

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Handling Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
086938409
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067047014CardioMEMS™CM1220CM12202026-03-13
05415067047021CardioMEMS™CM1250CM12502026-03-13
05415067047038CardioMEMS™CM1230CM12302026-03-13
05415067047045CardioMEMS™CM1210CM12102026-03-13
05415067048325CardioMEMS™CM1200CM12002026-03-13
05415067049612CardioMEMS™CM1260CM12602026-03-13
05415067054838CardioMEMS™CM1200-RCM1200-R2026-03-13
05414734509800CardioMEMS™CM1100CM11002015-08-06
05414734509237CardioMEMS™CM2000CM20002014-10-29
05414734510035Merlin.netMN6000MN60002016-05-02
05415067034731CardioMEMS™CM3150CM31502022-04-27
05415067034915CardioMEMS™CM3120CM31202022-04-27
05414734509220CardioMEMS™CM1060CM10602023-06-22
05414734509299CardioMEMS™CM3020CM30202023-06-21
05414734509398CardioMEMS™CM3040CM30402023-06-21
05415067029331CardioMEMS™CM3000CM30002017-06-02
05414734509565CardioMEMS™GuidewireCM20102015-07-15
15414734509562CardioMEMS™GuidewireCM20102015-07-15
05414734509169CardioMEMS™CM1000CM10002014-10-29
05414734509176CardioMEMS™CM1010CM10102014-10-29

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
05414734510257CardioMEMS™ST. JUDE MEDICAL, INC.MOM2023-06-21
05415067034731CardioMEMS™CARDIOMEMS, INC.MOM2022-04-27