Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
FDA premarket approval P150012/S044 · decided 2018-01-07
Approval details
- PMA number
- P150012
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2017-10-20
- Decision date
- 2018-01-07
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.
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