ICD INOGEN VR DF4 (D010); ICD INOGEN VR DF1/IS1 (D011); ICD INOGEN DR DF4/IS1 (D012); ICD INOGEN DR DF1/IS1 (D013);
FDA premarket approval P960040/S516 · decided 2026-07-23
Approval details
- PMA number
- P960040
- Supplement
- S516
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ICD INOGEN VR DF4 (D010); ICD INOGEN VR DF1/IS1 (D011); ICD INOGEN DR DF4/IS1 (D012); ICD INOGEN DR DF1/IS1 (D013);
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2026-06-26
- Decision date
- 2026-07-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components
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