PMA P960004S109
- Device
- FINELINE II Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S109
- Product code
- NVN
- Decision date
- 2025-10-24
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- approval for updates to the Instructions for Use Manuals and Labels
Current openFDA PMA Record#
- Device
- FINELINE II Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S109
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2025-10-24
- Decision code
- APPR
- Date received
- 2025-07-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for updates to the Instructions for Use Manuals and Labels