PMA P960004S081
- Device
- FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S081
- Product code
- NVN
- Decision date
- 2017-09-20
- 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 to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.
Current openFDA PMA Record#
- Device
- FINELINE™ II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories)
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S081
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.