PMA P150012S007
- Device
- ESSENTIO VALITUDE™ MRI: L110, L111, L131;PROPONENT VALITUDE™ MRI: L210, L211, L231; ACCOLADE VALITUDE™ MRI: L310, L311,
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S007
- Product code
- LWP
- Decision date
- 2016-06-20
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Remove the final finish wetblast manufacturing process step.
Current openFDA PMA Record#
- Device
- ESSENTIO VALITUDE™ MRI: L110, L111, L131;PROPONENT VALITUDE™ MRI: L210, L211, L231; ACCOLADE VALITUDE™ MRI: L310, L311,
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S007
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-06-20
- Decision code
- OK30
- Date received
- 2016-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove the final finish wetblast manufacturing process step.