PMA P950001S014
- Device
- SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S014
- Product code
- DTB
- Decision date
- 2005-03-24
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
Current openFDA PMA Record#
- Device
- SELUTE FAMILY (INCLUDES SELUTE, SELUTE PICOTIP)
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S014
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2005-03-24
- Decision code
- OK30
- Date received
- 2005-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.