ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR
FDA premarket approval P960040/S489 · decided 2022-12-20
Approval details
- PMA number
- P960040
- Supplement
- S489
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-12-12
- Decision date
- 2022-12-20
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Manufacture the accelerometer cover component of pulse generator devices.
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