AMPLATZER DUCT OCCLUDER II
FDA premarket approval P020024/S037 · decided 2013-08-18
Approval details
- PMA number
- P020024
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMPLATZER DUCT OCCLUDER II
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-01-22
- Decision date
- 2013-08-18
- Days to decision
- 208 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE SECOND GENERATION AMPLATZER DUCT OCCLUDER II (ADO II) DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPLATZER DUCT OCCLUDER II AND IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSIUS (PDA).
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
| Amplatzer TorqVue Exchange System (K261631) | Abbott Medical | 2026-06-17 |
| OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459) | ABBOTT MEDICAL | 2026-04-24 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
| Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499) | ABBOTT MEDICAL | 2026-03-13 |
| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |