ESSENTIO MRI Models L110, L111, L131;
FDA premarket approval P150012/S020 · decided 2016-12-12
Approval details
- PMA number
- P150012
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI Models L110, L111, L131;
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-11-18
- Decision date
- 2016-12-12
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Additional manufacturing inspection step along with associated specification and inspection criteria that will allow pulse generator case half discontinuities to be distinguished from dents.
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