ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers
FDA premarket approval P150012/S048 · decided 2017-12-06
Approval details
- PMA number
- P150012
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-11-20
- Decision date
- 2017-12-06
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.
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