FDA.reportPublic FDA data

Impella

Primary DI
00813502011401
Brand
Impella
Company
Abiomed, Inc.
Model
0042-0040-US
Catalog number
0042-0040-US
Device description
Optical, AIC, Impella Connect, Pkgd, US
Published
2023-07-31
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
OZDTemporary Non-Roller Type Left Heart Support Blood Pump
PYXTemporary Non-Roller Type Right Heart Support Blood Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZDTemporary Non-Roller Type Left Heart Support Blood PumpUnknown3
PYXTemporary Non-Roller Type Right Heart Support Blood PumpCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P140003000
P170011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140003000IMPELLA 2.5 SystemAbiomed, Inc.2015-03-23OZD
P170011000Impella RP SystemAbiomed, Inc.2017-09-20PYX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502011401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502011401008135020114018135020114010813502011401

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac circulatory assist axial-pump catheter control unitA mains electricity (AC-powered) device designed to operate and monitor an intracardiac circulatory assist axial-pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It typically consists of operator controls, a monitoring interface, a low-voltage connection to drive the impeller, a fluid purging pump, and provides backup power when line power is not available during transport. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary.

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
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-3052 2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit 0052-3053 2026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013566Impella CP with SmartAssist100041310004132025-11-14
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502010015Impella0052-00110052-00112016-10-21
00813502011173Impella0046830046832014-09-03
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502011388Impella0048-00320048-00032023-07-31
00813502011371Impella0048-00240048-00032019-04-18
00813502011876Impella0048-00450048-00032023-07-31
00813502013269Abiomed 14Fr Low Profile Introducer100045810004582024-05-13
00813502012279Impella10000800048-00032023-07-31
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813502013566Impella CP with SmartAssistAbiomed, Inc.OZD2025-11-14
00813502010985ImpellaAbiomed, Inc.PYX2023-08-08
00813502010985ImpellaAbiomed, Inc.OZD2023-08-08
00813502011388ImpellaAbiomed, Inc.OZD2023-07-31
00813502011876ImpellaAbiomed, Inc.OZD2023-07-31
00813502012279ImpellaAbiomed, Inc.OZD2023-07-31
00813502012477ImpellaAbiomed, Inc.PYX2023-06-19
00813502012477ImpellaAbiomed, Inc.OZD2023-06-19
00813502010510ImpellaAbiomed, Inc.OZD2023-06-19
00813502011869ImpellaAbiomed, Inc.PYX2023-06-19
00813502012460ImpellaAbiomed, Inc.OZD2023-06-19
00813502012828Impella Abiomed, Inc.OZD2023-06-19
00813502013030ImpellaAbiomed, Inc.OZD2023-06-19
04260113630174ImpellaAbiomed, Inc.OZD2023-06-19
04260113630259Impella Abiomed, Inc.OZD2023-06-19
04260113630259Impella Abiomed, Inc.PYX2023-06-19
00813502012811Impella Abiomed, Inc.PYX2023-02-15
00813502011531ImpellaAbiomed, Inc.OZD2020-04-15
00813502011371ImpellaAbiomed, Inc.OZD2019-04-18
04260113630303ImpellaAbiomed, Inc.OZD2016-10-21
04260113630310ImpellaAbiomed, Inc.OZD2016-10-21
04260113630327ImpellaAbiomed, Inc.OZD2016-10-21
00813502010022ImpellaAbiomed, Inc.OZD2016-10-21
00813502010022ImpellaAbiomed, Inc.PYX2016-10-21
00813502010114ImpellaAbiomed, Inc.OZD2016-10-21
00813502010138ImpellaAbiomed, Inc.OZD2016-10-21
00813502010480ImpellaAbiomed, Inc.OZD2016-10-21
00813502011302ImpellaAbiomed, Inc.OZD2016-10-21
00813502011364ImpellaAbiomed, Inc.OZD2016-10-21
00081350201002ImpellaAbiomed, Inc.OZD2016-01-20