D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI
FDA premarket approval P960040/S510 · decided 2025-10-22
Approval details
- PMA number
- P960040
- Supplement
- S510
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MI
- Applicant
- Boston Scientific
- Date received
- 2025-09-26
- Decision date
- 2025-10-22
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add an alternative Macro Laser Weld System to perform the laser weld process on high voltage ICD and CRT-D devices
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