Amplatzer Piccolo™

Primary DI
05415067031013
Brand
Amplatzer Piccolo™
Company
ST. JUDE MEDICAL, INC.
Model
9-PDAP-04-04-L
Catalog number
9-PDAP-04-04-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
05415067031013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067031013054150670310135415067031013

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
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16
05415067031600Navitor™NVTR-29NVTR-292023-01-16
05415067010728Portico™PRT-23PRT-232021-09-20
05415067012487Portico™PRT-25PRT-252021-09-20
05415067012494Portico™PRT-27PRT-272021-09-20
05415067012500Portico™PRT-29PRT-292021-09-20
05415067031914Aveir™LSL02LSL022023-03-03
05415067030092Advisor™H702532H7025322019-09-23
05415067031471Advisor™H702520H7025202019-09-23
05415067017031WorkMate Claris™H701703H7017032017-04-06
05415067024756EnSite Precision™ Link, Sensor Enabled™H702475H7024752016-12-20
05415067026149N/AH702499H7024992016-12-08
05415067026163EnSite™H702498-TH702498-T2016-12-20
05415067026194EnSite™H702500H7025002016-12-08
05415067026200EnSite™H702500-TH702500-T2016-12-08
05415067052742Epic™ESP300-23ESP300-232026-07-08
05415067052759Epic™EELT-23AEELT-23A2026-07-08
05415067052766Epic™EELT-31MEELT-31M2026-07-08

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
05415067031006Amplatzer 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