DURATA LEADS
FDA premarket approval P950022/S079 · decided 2012-09-13
Approval details
- PMA number
- P950022
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURATA LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-11-07
- Decision date
- 2012-09-13
- Days to decision
- 311 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE HELIX-SHAFT SUBASSEMBLY OF MARKET APPROVED TENDRIL MODELS 1882, 1888, 1988, 2088 AND DURATA MODELS 7120Q, 7121Q, 7122Q, 7120, 7121, 7122, 7130, AND 7131 LEADS FOR IMPROVED MANUFACTURABILITY AND COST.
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 |