FDA.reportPublic FDA data

PA 10

Primary DI
04035479131609
Brand
PA 10
Company
BIOTRONIK SE & Co. KG
Model
394500
Catalog number
394500
Published
2014-08-20
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
NVYPermanent defibrillator electrodes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVYPermanent Defibrillator ElectrodesUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P980023057

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P980023057PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMBiotronik, Inc.1998-10-27LWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479131609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479131609040354791316094035479131609

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator analyser cable, single-useAn electrical conductor used to connect a pulse generator analyser to the leads of an implantable pulse generator (IPG) [i.e., an implantable pacemaker or automatic implantable cardioverter-defibrillator (AICD)] to test the function of the generator during the implantation procedure. It is typically an assembly of insulated wires (e.g., 2-4 meters in length) that terminate into several leads, each having a connector (e.g., an alligator clip) that connects to the implantable pacing leads (e.g., IS-1 leads) of the pulse generator, and with a connector at the proximal end that connects either directly or via an adaptor to the pulse generator analyser. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit131 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479190705NEO 2601.U4991024991022026-09-21
04035479190712PSW 2601.U4991034991032026-09-21
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000643430OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643454OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643478OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000643539OmniaSecure™ MRI SureScan™MEDTRONIC, INC.NVY2025-12-19
00763000180010Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180034Sprint Quattro Secure S™MEDTRONIC, INC.NVY2024-11-04
00763000180041Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180058Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180119Sprint Quattro Secure S MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180232Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180256Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180263Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180317Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180324Sprint Quattro Secure MRI™ SureScan™MEDTRONIC, INC.NVY2024-11-04
00763000180331Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000180348Sprint Quattro Secure™MEDTRONIC, INC.NVY2024-11-04
00763000369743Epsila EV™MEDTRONIC, INC.NVY2023-11-03
00763000368470Aurora EV-ICD™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000369767Epsila EV™ MRI SureScan™MEDTRONIC, INC.NVY2023-11-02
00763000571528NAMEDTRONIC, INC.NVY2023-07-30
00763000740269SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2022-12-11
00763000059385NAMEDTRONIC, INC.NVY2018-12-22
00763000130800SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00763000130817SelectSecure™ MRI SureScan™MEDTRONIC, INC.NVY2018-10-11
00643169410954CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00643169448957CapSure Sense MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-26
00763000014643CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20
00763000014667CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20
00763000014704CapSureFix Novus MRI™ SureScan™MEDTRONIC, INC.NVY2017-10-20