- Device
- SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S053
- 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
- 2021-09-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use a new controlled environment area at the Boston Scientific Dorado, Puerto Rico facility.