PMA P950001S023
- Device
- SELUTE LEAD SYSTEM FAMILY
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S023
- Product code
- NVY
- Decision date
- 2012-04-23
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
Current openFDA PMA Record#
- Device
- SELUTE LEAD SYSTEM FAMILY
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S023
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2012-04-23
- Decision code
- OK30
- Date received
- 2012-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.