Fineline II Sterox and Sterox EZ Lead
FDA premarket approval P960004/S080 · decided 2017-05-23
Approval details
- PMA number
- P960004
- Supplement
- S080
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Fineline II Sterox and Sterox EZ Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2017-04-26
- Decision date
- 2017-05-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Changes to the quality control analytical test methods used to evaluate dexamethasone acetate for passive fixation distal tip subassembly test articles.
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