Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
FDA premarket approval P030035/S208 · decided 2025-06-17
Approval details
- PMA number
- P030035
- Supplement
- S208
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-03-19
- Decision date
- 2025-06-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| 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 |
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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 |