RIATA ST LEAD MODELS 7000, 7001, AND 7002
FDA premarket approval P950022/S024 · decided 2005-06-03
Approval details
- PMA number
- P950022
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIATA ST LEAD MODELS 7000, 7001, AND 7002
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-04-21
- Decision date
- 2005-06-03
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR ADDITION OF THE RIATA ST LEAD MODELS 7000, 7001, AND 7002 TO THE RIATA DEFIBRILLATION LEAD SYSTEM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RIATA ST MODELS 7000, 7001, AND 7002 AND ARE INDICATED FOR USE WITH COMPATIBLE PULSE GENERATORS.
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 |