ESSENTIO VALITUDE MRI: L110, L111, L131;PROPONENT VALITUDE MRI: L210, L211, L231; ACCOLADE VALITUDE MRI: L310, L311,
FDA premarket approval P150012/S007 · decided 2016-06-20
Approval details
- PMA number
- P150012
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO VALITUDE MRI: L110, L111, L131;PROPONENT VALITUDE MRI: L210, L211, L231; ACCOLADE VALITUDE MRI: L310, L311,
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-05-26
- Decision date
- 2016-06-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Remove the final finish wetblast manufacturing process step.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.