PMA P950001S013
- Device
- SELUTE, SELUTE PICOTIP
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S013
- Product code
- DTB
- Decision date
- 2004-12-22
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- SELUTE, SELUTE PICOTIP
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S013
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2004-12-22
- Decision code
- OK30
- Date received
- 2004-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF A NEW BIOLOGICAL INDICATOR FOR THE STERILIZATION PROCESS.