FINELINE® II EZ Sterox
FDA premarket approval P960004/S106 · decided 2025-08-22
Approval details
- PMA number
- P960004
- Supplement
- S106
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE® II EZ Sterox
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2023-11-01
- Decision date
- 2025-08-22
- Days to decision
- 660 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for changes to the cleaning equipment and solvent used to clean helices used in Boston Scientific Corporation cardiac leads
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