Nit-Occlud PDA

Primary DI
04042301159977
Brand
Nit-Occlud PDA
Company
pfm medical ag
Model
145065V2
Catalog number
145065V2
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
P120009003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120009003NIT-OCCLUD PDAPfm Medical, Inc.2013-08-16MAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4042301159984PackageGS110In Commercial Distribution
04042301159977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4042301159984040423011599844042301159984
04042301159977040423011599774042301159977

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac defect occluderAn implantable disk-like device intended to be used 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) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
7607588749regulatory@pfmmedicalusa.com

Regulatory Flags#

DUNS number
316661214
Device count
1
Kit
true
Lot or batch
true
Serial number
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
04042301159991Nit-Occlud PDA145076V2145076V22014-08-06
04042301160010Nit-Occlud PDA145096V2145096V22014-08-06
04042301160034Nit-Occlud PDA145116V2145116V22014-08-06
04042301159939Nit-Occlud PDA145044V2145044V22014-08-06
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
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