Assurity MRI, Endurity MRI
FDA premarket approval P140033/S085 · decided 2024-03-26
Approval details
- PMA number
- P140033
- Supplement
- S085
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Assurity MRI, Endurity MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-01-02
- Decision date
- 2024-03-26
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- expansion of MR Conditional labeling of Endurity MRI and Assurity MRI pacemakers with Tendril STS 2088TC or UltiPace LPA1231 bradycardia leads placed in the left bundle branch area
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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 |
| EnSite™ X EP System (K260212) | ABBOTT MEDICAL | 2026-04-20 |
| 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 |