LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC,
FDA premarket approval P910073/S180 · decided 2024-11-07
Approval details
- PMA number
- P910073
- Supplement
- S180
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF SC, LD SEN DF4 IB IR PF DC, LD SEN DF4 IB IR AF SC,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2024-11-06
- Decision date
- 2024-11-07
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- a software update to the Sensofar machine
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