ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM
FDA premarket approval P960040/S487 · decided 2022-10-14
Approval details
- PMA number
- P960040
- Supplement
- S487
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-10-12
- Decision date
- 2022-10-14
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implement an Automated Optical Inspection System for inspection of capacitor components at a supplier.
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