PMA P950001S005
- Device
- SELUTE(R) STEROID-ELUTING LEAD
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S005
- Product code
- DTB
- Decision date
- 2000-03-10
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Approval is for the use of a modified suture sleeve.
Current openFDA PMA Record#
- Device
- SELUTE(R) STEROID-ELUTING LEAD
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S005
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2000-03-10
- Decision code
- APPR
- Date received
- 1999-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval is for the use of a modified suture sleeve.