PMA P960004S090
- Device
- FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S090
- Product code
- NVN
- Decision date
- 2019-07-31
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- approval for enhancements and modifications to existing market released products including hardware, MRI labeling and manufacturing changes as well as software updates
Current openFDA PMA Record#
- Device
- FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S090
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-07-31
- Decision code
- APPR
- Date received
- 2019-05-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for enhancements and modifications to existing market released products including hardware, MRI labeling and manufacturing changes as well as software updates