Imageready MR Conditional Pacing System and Ingevity PACE/SENSE Lead
FDA premarket approval P150012/S104 · decided 2021-02-02
Approval details
- PMA number
- P150012
- Supplement
- S104
- 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
- 2020-11-17
- Decision date
- 2021-02-02
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a software maintenance release for the Model 3892 Altrua, Insignia I, and Nexus I software application on the Model 3300 LATITUDE Programming System.
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