Nit-Occlud PDA

Primary DI
04042301159939
Brand
Nit-Occlud PDA
Company
pfm medical ag
Model
145044V2
Catalog number
145044V2
Device description
Nit-Occlud® PDA is a system for transcatheter occlusion of Patent Ductus Arteriosus (PDA) with spiral coils. The system consists of a spiral coil mounted in a straightened fashion on a flexible delivery system including a disposable handle. The Nit-Occlud® PDA has a cone in cone configuration which results from the fact that the proximal windings of the coil are wound the reverse direction. Nit-Occlud® PDA is available as Flexible and Medium Type. The flexible and medium types are pre-loaded into the transportation sheath.
Published
2014-08-06
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
P120009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120009000NIT-OCCLUD PDAPfm Medical, Inc.2013-08-16MAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4042301159946PackageGS110In Commercial Distribution
04042301159939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4042301159946040423011599464042301159946
04042301159939040423011599394042301159939

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderAn implantable disk-like device intended for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. 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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7607588749spalomares@pfmmedicalusa.com

Regulatory Flags#

DUNS number
316661214
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042301159953Nit-Occlud PDA145054V22014-08-06
04042301159977Nit-Occlud PDA145065V2145065V22014-08-06
04042301159991Nit-Occlud PDA145076V2145076V22014-08-06
04042301160010Nit-Occlud PDA145096V2145096V22014-08-06
04042301160034Nit-Occlud PDA145116V2145116V22014-08-06
4042301159960Nit-Occlud PDA145054V22014-08-06
4042301159984Nit-Occlud PDA145065V2145065V22014-08-06
4042301160003Nit-Occlud PDA145076V2145076V22014-08-06
4042301160027Nit-Occlud PDA145096V2145096V22014-08-06
4042301160041Nit-Occlud PDA145116V2145116V22014-08-06

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
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
4042301159960Nit-Occlud PDApfm medical agMAE2014-08-06
4042301159984Nit-Occlud PDApfm medical agMAE2014-08-06
4042301160003Nit-Occlud PDApfm medical agMAE2014-08-06