PMA P960004S088
- Device
- Fineline II Sterox, EZ.
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S088
- Product code
- NVN
- Decision date
- 2019-02-28
- 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 the sales packaging and label changes being made to BSC lead families.
Current openFDA PMA Record#
- Device
- Fineline II Sterox, EZ.
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S088
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the sales packaging and label changes being made to BSC lead families.