Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,
FDA premarket approval P960040/S428 · decided 2018-09-04
Approval details
- PMA number
- P960040
- Supplement
- S428
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-08-30
- Decision date
- 2018-09-04
- Days to decision
- 5 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Addition of an alternate supplier for the molybdenum feedthru pin.
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