Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models
FDA premarket approval P960040/S508 · decided 2025-09-22
Approval details
- PMA number
- P960040
- Supplement
- S508
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Cardioverter Defibrillator, INOGEN (Models D010, D011, D012, D013, D140, D141, D142, D143); DYNAGEN (Models
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2025-08-26
- Decision date
- 2025-09-22
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to update device testing software and make a supplier-related wafer subcomponent change
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