Amplatzer Piccolo™

Primary DI
05415067030993
Brand
Amplatzer Piccolo™
Company
ST. JUDE MEDICAL, INC.
Model
9-PDAP-03-06-L
Catalog number
9-PDAP-03-06-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
05415067030993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067030993054150670309935415067030993

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 Diameter3Millimeter

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
05415067053039Current™PFA-AMP-RETURN-CBLPFA-AMP-RETURN-CBL2026-08-03
05415067055002Current™PFA-TSQ-CBLPFA-TSQ-CBL2026-08-03
05415067055583Current™PFA-GEN-OVERLAY-FPFA-GEN-OVERLAY-F2026-08-03
05415067055897Current™PFA-GEN-V110PFA-GEN-V1102026-08-03
00811806011295Amplatzer™9-PFO-0309-PFO-0302026-07-31
05415067045447Epic™EMAX-21EMAX-212023-08-01
05415067045454Epic™EMAX-25EMAX-252023-08-01
05415067045461Epic™EMAX-19EMAX-192023-08-01
05415067045478Epic™EMAX-23EMAX-232023-08-01
05415067033017Epic™E200-21AE200-21A2021-12-09
05415067033024Epic™E200-23AE200-23A2021-12-09
05415067033031Epic™E200-25AE200-25A2021-12-09
05415067033048Epic™E200-25ME200-25M2021-12-09
05415067033055Epic™E200-27AE200-27A2021-12-09
05415067033062Epic™E200-27ME200-27M2021-12-09
05415067033079Epic™E200-29AE200-29A2021-12-09
05415067033086Epic™E200-29ME200-29M2021-12-09
05415067033093Epic™E200-31ME200-31M2021-12-09
05415067033109Epic™E200-33ME200-33M2021-12-09
05415067033116Epic™ESP200-19ESP200-192021-12-09

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
05415067031006Amplatzer 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