PMA P150012S085
- Device
- INGEVITY
- Applicant
- Boston Scientific
- Product code
- LWP
- Decision date
- 2019-12-16
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modify the terminal pin to pin cap laser welding process for INGEVITY leads.
Current openFDA PMA Record#
- Device
- INGEVITY
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S085
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-12-16
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the terminal pin to pin cap laser welding process for INGEVITY leads.