FDA.reportPublic FDA data

SQ-RX® PULSE GENERATOR

Primary DI
00802526521300
Brand
SQ-RX® PULSE GENERATOR
Company
CAMERON HEALTH, INC.
Model
1010
Device description
SQ-RX Pulse Generator
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110042000
P110042002
P110042003
P110042004
P110042007
P110042011
P110042012
P110042014
P110042016
P110042021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110042000SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042002SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042003SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042004SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042007SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042011SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042012SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042014SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042016SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS
P110042021SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMBoston Scientific Corporation2012-09-28LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00802526521300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802526521300008025265213008025265213000802526521300

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017134557
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526562808SQ-RX® PULSE GENERATOR10102014-09-24
00802526563201The Q-TRAK™ Subcutaneous Electrode34002014-09-24
00802526542206Q TECH32002014-09-24
00802526524806S-ICD® System Patient Screening Tool47442014-09-24
00802526531019The Q-GUIDE™ Electrode Insertion Tool47102014-09-24
00802526531033S-ICD® System Magnet47302014-09-24
00802526542244Q-TECH™32042015-01-08
00802526553707HP OFFICEJET 100 Mobile Printer47002014-09-24
00802526569401The Q-GUIDE™ Electrode Insertion Tool47102014-09-24

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Primary DI, Brand, Company table
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