FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)
FDA premarket approval P960004/S078 · decided 2017-04-11
Approval details
- PMA number
- P960004
- Supplement
- S078
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FINELINE II STEROX & FINELINE II STEROX EZ, SUTURE SLEEVE ACCESSORY(FOR FINELINE II LEADS)
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 2016-12-09
- Decision date
- 2017-04-11
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the addition of 3T MR Conditional labeling for the Image Ready MR Conditional Pacing System consisting of an Accolade MRI pacemaker with one or two INGEVITY MRI leads. In addition, you requested approval to expand the Image Ready System to include 1.5T MR Conditional labeling for the FINELINE II Sterox and Sterox EZ leads.
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