PERCEVAL PLUS

GUDID 00896208000825

Livanova Canada Corp

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID00896208000825
NIH Device Record Keya0bd4fb6-2a9e-4dfd-b102-41af3e30799a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERCEVAL PLUS
Version Model NumberPVF-XL
Company DUNS243661431
Company NameLivanova Canada Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896208000825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-03
Device Publish Date2021-01-26

On-Brand Devices [PERCEVAL PLUS]

00896208000825PVF-XL
00896208000818PVF-L
00896208000801PVF-M
00896208000795PVF-S

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.