PMA P150012S026
- Device
- ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S026
- Product code
- LWP
- Decision date
- 2017-03-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Change to the method of cleaning a soldering iron tip; 2) changes to the cleaning process of the trays; 3) modification of the solder fixture; and 4) changes to the cleaning of the solder fixture.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S026
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-03-29
- Decision code
- OK30
- Date received
- 2017-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the method of cleaning a soldering iron tip; 2) changes to the cleaning process of the trays; 3) modification of the solder fixture; and 4) changes to the cleaning of the solder fixture.