PMA P150012S106
- Device
- INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S106
- Product code
- LWP
- Decision date
- 2021-01-13
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.
Current openFDA PMA Record#
- Device
- INGEVITY™ non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY™ non-MRI Lead Passive Fixation, Ventricular, INGEV
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S106
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-01-13
- Decision code
- OK30
- Date received
- 2021-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.