- Device
- FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP,
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S096
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.