PMA P150012S010
- Device
- INGEVITY MRI LEAD, INGEVITY Non-MRI Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S010
- Product code
- LWP
- Decision date
- 2016-07-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modified welding fixture for use in the manufacturing of the Ingevity family of pacemaker leads.
Current openFDA PMA Record#
- Device
- INGEVITY MRI LEAD, INGEVITY Non-MRI Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S010
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-07-26
- Decision code
- OK30
- Date received
- 2016-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modified welding fixture for use in the manufacturing of the Ingevity family of pacemaker leads.