FDA.reportPublic FDA data

Myopore® Sutureless Myocardial Pacing Lead

Primary DI
00821329900228
Brand
Myopore® Sutureless Myocardial Pacing Lead
Company
Greatbatch Ltd
Model
511212
Device description
Myopore® Bipolar Sutureless Pacing Lead
Published
2015-05-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTBPermanent Pacemaker Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTBPermanent Pacemaker ElectrodeCardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821329900228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821329900228008213299002288213299002280821329900228

GMDN Terms#

Term, Definition table
TermDefinition
Epicardial pacing leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium), and the other end is connected to the pacemaker. It may be impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Regulatory Flags#

DUNS number
968623467
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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00821329000355PTFE Peelable Introducer Kit667091-35170912017-10-26
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00821329000416Greatbatch Steerable Sheath10876-00110876-0012017-10-19
00821329000423Greatbatch Steerable Sheath10876-00210876-0022017-10-19
00821329000430RadialSeal™ Introducer Kit, SS WireSPC-000653-0072018-09-24
00821329000447RadialSeal™ Introducer Kit, SS WireSPC-000653-0092018-09-24
00821329000454RadialSeal™ Introducer Kit, SS WireSPC-000653-0082018-09-24
00821329000461RadialSeal™ Introducer Kit, Poly WireSPC-000654-0072018-09-24
00821329000478RadialSeal™ Introducer Kit, Poly WireSPC-000654-0082018-09-24
00821329000485RadialSeal™ Introducer Kit, Poly WireSPC-000654-0092018-09-24
00821329000508PTFE Peelable Introducer Kit667131-35171312017-10-26
00821329000515PTFE Peelable Introducer Kit667133-35171332017-10-26
00821329000522PTFE Peelable Introducer Kit667090-35170902017-10-26
00821329000539PTFE Peelable Introducer Kit667096-35170962017-10-26

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