PMA P150012S111
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S111
- Product code
- LWP
- Decision date
- 2021-05-10
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.
Current openFDA PMA Record#
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S111
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-05-10
- Decision code
- OK30
- Date received
- 2021-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.