IsoFlex (1944)
FDA premarket approval P960030/S081 · decided 2025-08-27
Approval details
- PMA number
- P960030
- Supplement
- S081
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IsoFlex (1944)
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-05-29
- Decision date
- 2025-08-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- expansion of MR Conditial labeling for IsoFlex model 1944 pacing leads and additional Quartet LV pacing leads (75cm and 92cm) when combined with Avant, Gallant, Entrant, and Neutrino NxT implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds).
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