Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
FDA premarket approval P150012/S095 · decided 2020-06-19
Approval details
- PMA number
- P150012
- Supplement
- S095
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2020-05-22
- Decision date
- 2020-06-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150012/S083.
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