PMA P150012S063
- Device
- INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S063
- Product code
- LWP
- Decision date
- 2018-07-05
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Addition of new molding preparation equipment with updated software, application of existing overmolding equipment already in use for other leads, and duplication of existing process monitoring testing to monitor output of the added equipment.
Current openFDA PMA Record#
- Device
- INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S063
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-07-05
- Decision code
- OK30
- Date received
- 2018-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new molding preparation equipment with updated software, application of existing overmolding equipment already in use for other leads, and duplication of existing process monitoring testing to monitor output of the added equipment.