PMA P960004S100
- Device
- Fineline II Sterox, Sterox EZ pace / sense leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S100
- Product code
- NVN
- Decision date
- 2022-07-28
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Add a specification and inspection for a component of the packaging.
Current openFDA PMA Record#
- Device
- Fineline II Sterox, Sterox EZ pace / sense leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S100
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2022-07-28
- Decision code
- OK30
- Date received
- 2022-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a specification and inspection for a component of the packaging.