Multi-Application Utility Model, (Non-Implantable Accessories)
FDA premarket approval P910077/S161 · decided 2017-09-20
Approval details
- PMA number
- P910077
- Supplement
- S161
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Multi-Application Utility Model, (Non-Implantable Accessories)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-05-26
- Decision date
- 2017-09-20
- Days to decision
- 117 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.
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