MRI Pacemakers
FDA premarket approval P150012/S084 · decided 2019-10-29
Approval details
- PMA number
- P150012
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MRI Pacemakers
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2019-10-21
- Decision date
- 2019-10-29
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.