PMA P150012S069
- Device
- Ingevity Lead Family (passive fixation models)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S069
- Product code
- LWP
- Decision date
- 2019-01-10
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.
Current openFDA PMA Record#
- Device
- Ingevity Lead Family (passive fixation models)
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S069
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-01-10
- Decision code
- OK30
- Date received
- 2018-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.