ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I
FDA premarket approval P960040/S480 · decided 2022-07-22
Approval details
- PMA number
- P960040
- Supplement
- S480
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-07-21
- Decision date
- 2022-07-22
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change the second-tier supplier of the Analog integrated circuits (ICs) used in ICD and CRT-D pulse generators.
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