PMA P960004S082
- Device
- FINELINE II Lead Family
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S082
- Product code
- NVN
- Decision date
- 2018-02-08
- 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
- Implementation of serial number reading stations with optical character recognition equipment and software for use in lead manufacturing.
Current openFDA PMA Record#
- Device
- FINELINE II Lead Family
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S082
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-02-08
- Decision code
- OK30
- Date received
- 2018-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of serial number reading stations with optical character recognition equipment and software for use in lead manufacturing.