FDA.reportPublic FDA data

EluPro Antibiotic-Eluting BioEnvelope

Primary DI
00859389005331
Brand
EluPro Antibiotic-Eluting BioEnvelope
Company
Elutia Med LLC
Model
CMCV-124-MED
Device description
The EluPro Antibiotic-Eluting BioEnvelope is a sterile pouch designed to hold a cardiac implantable device or implantable neurostimulator device to create a stable environment when implanted in the body. EluPro consists of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) and resorbable, ring- shaped poly(D,L Lactide-Co-Glycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for the natural flow of exudate through the device. The drug-eluting polymer discs are secured between the multilaminate sheets on each side and the envelope is constructed with 5-0 polydioxanone (PDS) suture. EluPro contains 10.5 mg of rifampin and 9.3 mg of minocycline.
Published
2024-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859389005338PackageGS15Not in Commercial Distribution
00859389005331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085938900533810859389005338
00859389005331008593890053318593890053310859389005331

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
080924060
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859389005027CanGaroo EnvelopeCMCV-009-SML2015-07-01
00859389005034CanGaroo EnvelopeCMCV-009-MED2015-07-01
00859389005065CanGaroo EnvelopeCMCV-009-LRG2015-07-01
00859389005072CanGaroo EnvelopeCMCV-009-XLG2015-07-01
00859389005119CanGaroo EnvelopeCMCV-009-XXL2019-02-28
04035479160555Biotronik BioEnvelope4405792019-08-26
00859389005348EluPro Antibiotic-Eluting BioEnvelopeCMCV-124-LRG2024-09-06
04035479160517Biotronik BioEnvelope4405752019-08-26
04035479160524Biotronik BioEnvelope4405762019-08-26
04035479160531Biotronik BioEnvelope4405772019-08-26
04035479160548Biotronik BioEnvelope4405782019-08-26
00859389005010ProxiCor for Pericardial ClosureCMCV-060-4022015-06-30
00859389005041ProxiCor for Cardiac Tissue RepairCMCV-064-4012015-06-30
00859389005058ProxiCor for Cardiac Tissue RepairCMCV-067-4042015-07-01
00859389005089VasCure for Carotid RepairCMCV-072-6062015-07-01
00859389005096VasCure for Carotid RepairCMCV-073-6092015-07-01
00859389005102Tyke, Patch, Pledget and IntracardiacCMCV-098-2042019-02-28
00859389005126VasCure for Vascular RepairCMCV-011-6062015-07-01
00859389005140VasCure for Vascular RepairCMCV-013-6092015-07-01
00859389005003ProxiCor for Pericardial ClosureCMCV-059-4012015-04-29

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Primary DI, Brand, Company table
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00802526629938CanGaroo®Boston Scientific CorporationFTM2026-05-27
00802526629945CanGaroo®Boston Scientific CorporationFTM2026-05-27
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