PMA P960004S101
- Device
- Thinline Endocardial Pacing Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S101
- Product code
- NVN
- Decision date
- 2022-11-02
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.
Current openFDA PMA Record#
- Device
- Thinline Endocardial Pacing Leads
- Applicant
- Boston Scientific
- PMA number
- P960004
- Supplement
- S101
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2022-11-02
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.