Assurity MRI, Endurity MRI
FDA premarket approval P140033/S068 · decided 2021-08-13
Approval details
- PMA number
- P140033
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Assurity MRI, Endurity MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-04-08
- Decision date
- 2021-08-13
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for use of two new MRI inductor component models in Assurity and Endurity MRI pacemaker devices and to add an alternate supplier of these components.
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |