FDA.reportPublic FDA data

Impella

Primary DI
00813502011869
Brand
Impella
Company
Abiomed, Inc.
Model
0046-0035
Catalog number
0046-0035
Device description
RP w Smart Assist Set, US
Published
2023-06-19
Public version status
New
Distribution status
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
PYXTemporary Non-Roller Type Right Heart Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYXTemporary Non-Roller Type Right Heart Support Blood PumpCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170011030

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170011030Impella RP SystemAbiomed, Inc.2017-09-20PYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502011869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502011869008135020118698135020118690813502011869

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
050636737
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-30522026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit0052-30532026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013269Abiomed 14Fr Low Profile Introducer100045810004582024-05-13
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31
00813502011791Impella0052-30690052-30692020-07-20
00813502011708Impella0052-00380052-00382020-04-15
00813502011715Impella0052-00390052-00392020-04-15
00813502010015Impella0052-00110052-00112016-10-21
00813502011302Impella0052-00010052-00012016-10-21
00813502011319Impella0052-00020052-00022016-10-24
00813502011364Impella0052-00070052-00072016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813502010985ImpellaAbiomed, Inc.PYX2023-08-08
00813502011401ImpellaAbiomed, Inc.PYX2023-07-31
00813502012477ImpellaAbiomed, Inc.PYX2023-06-19
04260113630259Impella Abiomed, Inc.PYX2023-06-19
00813502012811Impella Abiomed, Inc.PYX2023-02-15
00813502010022ImpellaAbiomed, Inc.PYX2016-10-21
00813502011029ImpellaAbiomed, Inc.PYX2016-01-20
00813502011135ImpellaAbiomed, Inc.PYX2014-07-31
00813502011289ImpellaAbiomed, Inc.PYX2014-07-31