PMA P150012S118
- Device
- Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S118
- Product code
- LWP
- Decision date
- 2021-10-04
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.
Current openFDA PMA Record#
- Device
- Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S118
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-10-04
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.