PMA P150012S038
- Device
- INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S038
- Product code
- LWP
- Decision date
- 2017-10-05
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modifications to improve the helix to coupler weld process and implement tighter control at the proximal end of the tip helix component.
Current openFDA PMA Record#
- Device
- INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S038
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-10-05
- Decision code
- OK30
- Date received
- 2017-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to improve the helix to coupler weld process and implement tighter control at the proximal end of the tip helix component.