PMA P150012S108
- Device
- INGEVITY MRI Pace/Sense Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S108
- Product code
- LWP
- Decision date
- 2021-04-02
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Update the automated Terminal Crimp System software used on INGEVITY MRI pace/sense leads.
Current openFDA PMA Record#
- Device
- INGEVITY MRI Pace/Sense Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S108
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the automated Terminal Crimp System software used on INGEVITY MRI pace/sense leads.