PMA P150012S008
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S008
- Product code
- LWP
- Decision date
- 2016-06-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Alternate sterilization recipe and addition of a new sterilization release mechanism.
Current openFDA PMA Record#
- Device
- IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S008
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-06-23
- Decision code
- OK30
- Date received
- 2016-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate sterilization recipe and addition of a new sterilization release mechanism.