AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM
FDA premarket approval P020024/S007 · decided 2006-05-12
Approval details
- PMA number
- P020024
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-11-16
- Decision date
- 2006-05-12
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATE PIGMENT TO BE USED DURING MANUFACTURE OF THE PTFE TUBING COMPONENTS OF THE AMPLATZER DELIVERY AND EXCHANGE SYSTEM SHEATHS, DILATORS AND LOADERS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |