AMPLATZER DUCT OCCLUDER
FDA premarket approval P020024/S014 · decided 2007-01-30
Approval details
- PMA number
- P020024
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMPLATZER DUCT OCCLUDER
- Generic name
- OCCLUDER, PATENT DUCTUS, ARTERIOSUS
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-11-07
- Decision date
- 2007-01-30
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE PACKAGING AND INCLUSION OF A THREE YEAR SHELF LIFE FOR THE ORIGINAL AMPLATZER DUCT OCCLUDER AND SEPTAL OCCLUDER DELIVERY AND EXCHANGE SYSTEMS.
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510(k) clearances by this applicant
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|---|---|---|
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |