ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead
FDA premarket approval P150012/S096 · decided 2020-08-26
Approval details
- PMA number
- P150012
- Supplement
- S096
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-07-02
- Decision date
- 2020-08-26
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for labeling updates for the ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead based on the SAMURAI and INGEVITY clinical studies.
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