PMA P150012S135
- Device
- Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S135
- Product code
- LWP
- Decision date
- 2022-11-02
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.
Current openFDA PMA Record#
- Device
- Imagerade MR Conditional Pacing System and Ingevity Pacing/Sense Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S135
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-11-02
- Decision code
- OK30
- Date received
- 2022-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace laser printers, finished goods box and tray label stock.