D010 INOGEN MINI ICD VR,D011 INOGEN MINI ICD VR,D012 INOGEN MINI ICD DR,D013 INOGEN MINI ICD DR,D020 DYNAGEN MINI I
FDA premarket approval P960040/S511 · decided 2025-10-22
Approval details
- PMA number
- P960040
- Supplement
- S511
- 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 MINI I
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-09-30
- Decision date
- 2025-10-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to extend the time that solder paste can remain on the stencil before cleaning when building pulse generator printed circuit board assemblies
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