Product code MAE
- Device name
- Occluder, Patent Ductus, Arteriosus
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P020024S073 | AmplatzerTM Duct Occluder | ABBOTT MEDICAL | 2026-05-28 |
| P020024S072 | Amplatzer™ Piccolo™ Occluder | ABBOTT MEDICAL | 2026-02-12 |
| P020024S071 | Amplatzer™ Duct Occluder; Amplatzer™ Duct Occluder II; Amplatzer Piccolo™ Occluder | ABBOTT MEDICAL | 2025-10-23 |
| P020024S070 | Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder | ABBOTT MEDICAL | 2024-12-13 |
| P120009S004 | NIT-OCCLUD PDA | Pfm Medical, Inc. | 2024-10-17 |
| P020024S069 | Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder | ABBOTT MEDICAL | 2024-10-01 |
| P020024S068 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2024-06-26 |
| P020024S067 | Amplatzer Piccolo™ Occluder | ABBOTT MEDICAL | 2023-03-27 |
| P020024S066 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II | ABBOTT MEDICAL | 2022-01-13 |
| P020024S065 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2021-07-27 |
| P020024S061 | AMPLATZER Duct Occluder | ABBOTT MEDICAL | 2020-10-06 |
| P020024S062 | Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2020-07-09 |
| P020024S064 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2020-06-04 |
| P020024S063 | AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo) | ABBOTT MEDICAL | 2020-05-23 |
| P020024S060 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2020-04-16 |
| P020024S059 | Amplatzer Duct Occluder/Amplatzer Duct Occluder II/Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2020-04-15 |
| P020024S058 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder | ABBOTT MEDICAL | 2019-10-25 |
| P020024S057 | AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM | ABBOTT MEDICAL | 2019-08-22 |
| P020024S056 | Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder | ABBOTT MEDICAL | 2019-03-25 |
| P020024S055 | AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder | ABBOTT MEDICAL | 2019-03-05 |
| P020024S052 | AMPLATZER Piccolo Occluder | ABBOTT MEDICAL | 2019-01-11 |
| P020024S053 | Amplatzer Duct Occluder/Amplatzer Duct Occluder II | ABBOTT MEDICAL | 2019-01-08 |
| P020024S051 | Amplatzer Duct Occluder / Amplatzer Duct Occluder II | ABBOTT MEDICAL | 2018-03-12 |
| P020024S048 | AMPLATZER Duct Occluder II | ABBOTT MEDICAL | 2017-09-21 |
| P020024S049 | AMPLATZER Duct Occluder | ABBOTT MEDICAL | 2017-08-03 |
| P020024S047 | AMPLATZER DUCT OCCLUDER/DUCT OCCLUDER II | ABBOTT MEDICAL | 2017-02-22 |
| P120009S003 | PMA NIT-OCCLUD PDA | Pfm Medical, Inc. | 2016-12-16 |
| P020024S046 | AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II | ABBOTT MEDICAL | 2016-08-04 |
| P020024S045 | AMPLATZER MULTI-FENESTRATED SEPTAL OCCULDER (CRIBRIFORM) | ABBOTT MEDICAL | 2016-05-04 |
| P020024S041 | AMPLATZER DUCT OCCLUDER AND DELIVERY AND EXCHANGE SYSTEMS | ABBOTT MEDICAL | 2016-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415067031051 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067031044 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067031037 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067031020 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067031013 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067031006 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067030993 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067030979 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 05415067030986 | Amplatzer Piccolo™ | ST. JUDE MEDICAL, INC. | 2019-01-18 |
| 00811806011189 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-19 |
| 00811806011233 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-15 |
| 00811806011219 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-15 |
| 00811806011202 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-15 |
| 00811806011172 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 00811806011141 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 00811806011103 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 00811806011110 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 00811806011127 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 00811806011134 | Amplatzer™ | ST. JUDE MEDICAL, INC. | 2014-09-08 |
| 04042301159953 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 4042301160041 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 04042301159977 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 04042301159991 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 04042301160010 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 04042301160034 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 04042301159939 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 4042301159960 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 4042301159984 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 4042301160003 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |
| 4042301160027 | Nit-Occlud PDA | pfm medical ag | 2014-08-06 |