FDA.reportPublic FDA data

Ellipse™

Primary DI
05414734506038
Brand
Ellipse™
Company
ST. JUDE MEDICAL, INC.
Model
CD1275-36Q
Catalog number
CD1275-36Q
Device description
Tiered-therapy cardioverter/defibrillator VVEV VVIR
Published
2017-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVZPulse generator, permanent, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVZPulse Generator, Permanent, ImplantableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910023279

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910023279CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMABBOTT MEDICAL1993-04-30LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734506038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734506038054147345060385414734506038

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable defibrillatorAn implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on one heart chamber (typically a ventricle) to monitor the ECG and to automatically deliver the electrical impulse to treat ventricular fibrillation or tachycardia. The device has internal batteries that provide the energy to deliver the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30.2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference.
Storage Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Expiration 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04035479173982Amvia Edge SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479173999Amvia Edge DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174019Amvia Sky SR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
04035479174026Amvia Sky DR-TBIOTRONIK SE & Co. KGNVZ2023-07-12
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