Amplatzer Piccolo™

Primary DI
05415067031006
Brand
Amplatzer Piccolo™
Company
ST. JUDE MEDICAL, INC.
Model
9-PDAP-04-02-L
Catalog number
9-PDAP-04-02-L
Device description
Duct Occluder
Published
2019-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAEOCCLUDER, PATENT DUCTUS, ARTERIOSUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAEOccluder, Patent Ductus, ArteriosusUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020024052
P020024062
P020024066
P020024067

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020024052AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMABBOTT MEDICAL2003-05-14MAE
P020024062AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMABBOTT MEDICAL2003-05-14MAE
P020024066AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMABBOTT MEDICAL2003-05-14MAE
P020024067AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMABBOTT MEDICAL2003-05-14MAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067031006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067031006054150670310065415067031006

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderA sterile, disk-like, device used for the non-surgical closure of cardiac defects. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester). It is implanted using a dedicated catheter/sheath and delivery cable. The device is used to treat cardiac disorders that may include, but not limited to; an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067054463Ampere™AMP-TFDM-01AMP-TFDM-012026-08-19
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05415067055651EnSite™ENSITE-D-FOCAL-01ENSITE-D-FOCAL-012026-08-19
05415067055668EnSite™ENSITE-D-PI-01ENSITE-D-PI-012026-08-19
05415067055675EnSite™ENSITE-PI-01ENSITE-PI-012026-08-19
05415067055682EnSite™ENSITE-FOCAL-01ENSITE-FOCAL-012026-08-19
05415067050724TriClip™TSGC0801TSGC08012025-12-11
05415067050908MitraClip™SGC0801SGC08012025-12-11
05415067051844Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-LSI-1371-L2025-02-07
05415067051851Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-MSI-1371-M2025-02-07
05415067050182Agilis™ NxT Steerable Introducer Dual-Reach™SI-1371-SSI-1371-S2024-08-15
05415067047748TriClip™TSGC0201TSGC02012024-04-12
05415067038487Aveir™LSCD201LSCD2012023-08-15
05415067036384Aveir™LSCD111LSCD1112023-03-03
05415067041517CPS AIM™DS2N100-59DS2N100-592022-10-20
05415067041524CPS Aim™DS2N100-65DS2N100-652022-10-20
05415067041586CPS AIM™DS2N104-65DS2N104-652022-10-20
05415067041739CPS AIM™DS2N101-65DS2N101-652022-10-20
05415067041746CPS AIM™DS2N103-65DS2N103-652022-10-20
05415067041753CPS AIM™DS2N102-65DS2N102-652022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067030979Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067030986Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067030993Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067031013Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067031020Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067031037Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067031044Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
05415067031051Amplatzer Piccolo™ST. JUDE MEDICAL, INC.MAE2019-01-18
00811806011189Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-19
00811806011202Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011219Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011233Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011240Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011257Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011264Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-15
00811806011103Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
00811806011110Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
00811806011127Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
00811806011134Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
00811806011141Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
00811806011172Amplatzer™ST. JUDE MEDICAL, INC.MAE2014-09-08
04042301159953Nit-Occlud PDApfm medical agMAE2014-08-06
04042301159977Nit-Occlud PDApfm medical agMAE2014-08-06
04042301159991Nit-Occlud PDApfm medical agMAE2014-08-06
04042301160010Nit-Occlud PDApfm medical agMAE2014-08-06
04042301160034Nit-Occlud PDApfm medical agMAE2014-08-06
04042301159939Nit-Occlud PDApfm medical agMAE2014-08-06
4042301159960Nit-Occlud PDApfm medical agMAE2014-08-06
4042301159984Nit-Occlud PDApfm medical agMAE2014-08-06
4042301160003Nit-Occlud PDApfm medical agMAE2014-08-06