FDA.reportPublic FDA data

NA

Primary DI
00763000185138
Brand
NA
Company
MEDTRONIC, INC.
Model
FP6000M
Device description
PROG DRAPE FP6000M W/WEIGHT MEDIUM DBS
Published
2020-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHYStimulator, electrical, implanted, for parkinsonian tremor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960009365

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960009365MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMedtronic, Inc.1997-07-31MHY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000185138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000185138007630001851387630001851380763000185138

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199309001242Percept™ PC BrainSense™MEDTRONIC, INC.MHY2026-08-07
00199309001259Percept™ RCMEDTRONIC, INC.MHY2026-08-07
00191506070595NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2026-06-08
00199309002416N/AMEDTRONIC, INC.MHY2026-05-29
00199150017850N/AMEDTRONIC, INC.MHY2026-02-05
00191506047276Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047283Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
00191506047290Vercise ™ DBSBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2025-02-24
08714729966333Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966340Vercise™ Cartesia™ XBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966357Vercise™ Cartesia™ HXBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966371NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966388NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729966395NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
08714729989240Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2024-12-15
00643169955653N'VISION®MEDTRONIC, INC.MHY2024-10-04
00191506014339Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2023-10-02
00191506014346Vercise™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2023-10-02
00191506023577NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2022-10-31
00191506023584NABOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2022-10-31
00763000404413N/AMEDTRONIC, INC.MHY2022-05-02
00763000274320DBS™MEDTRONIC, INC.MHY2021-12-16
00763000274399DBS™MEDTRONIC, INC.MHY2021-12-16
00763000274405DBS™MEDTRONIC, INC.MHY2021-12-16
00763000519216Percept™ PC BrainSense™MEDTRONIC, INC.MHY2021-10-17
00763000411916N/AMEDTRONIC, INC.MHY2021-07-30
08714729985037Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25
08714729985051Vercise Genus™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONMHY2021-06-25
00763000426378SenSight™MEDTRONIC, INC.MHY2021-06-05
00763000426385SenSight™MEDTRONIC, INC.MHY2021-06-05