- Device
- SELUTE PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S020
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2010-01-12
- Decision code
- OK30
- Date received
- 2009-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOLOGICAL INDICATOR USED FOR THE STERILIZATION PROCESS.