PMA P950001S015
- Device
- SELUTE AND SELUTE PICOTIP
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S015
- Product code
- DTB
- Decision date
- 2005-11-15
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS. THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS.
Current openFDA PMA Record#
- Device
- SELUTE AND SELUTE PICOTIP
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S015
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2005-11-15
- Decision code
- APPR
- Date received
- 2005-10-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE DRUG PLUG COMPONENT OF THE LEADS FROM ONE YEAR TO THREE YEARS. THE SHELF LIFE OF THE FINISHED LEADS REMAINS TWO YEARS.