PMA P950001S028
- Device
- SELUTE Pacing Lead Family
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S028
- Product code
- NVN
- Decision date
- 2016-06-23
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Alternate sterilization recipe and addition of a new sterilization release mechanism.
Current openFDA PMA Record#
- Device
- SELUTE Pacing Lead Family
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S028
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2016-06-23
- Decision code
- OK30
- Date received
- 2016-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate sterilization recipe and addition of a new sterilization release mechanism.