IsoFlex
FDA premarket approval P960030/S077 · decided 2022-12-07
Approval details
- PMA number
- P960030
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IsoFlex
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-09-08
- Decision date
- 2022-12-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.
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