PMA P950001S027
- Device
- SELUTE LEAD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S027
- Product code
- NVY
- Decision date
- 2014-07-30
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- SELUTE LEAD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S027
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-07-30
- Decision code
- OK30
- Date received
- 2014-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE DEVICES.