NG4 Family of Pulse Generators ICDS.
FDA premarket approval P960040/S385 · decided 2017-05-02
Approval details
- PMA number
- P960040
- Supplement
- S385
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NG4 Family of Pulse Generators ICDS.
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-10-28
- Decision date
- 2017-05-02
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for NG4 models of ICD and CRT-D devices with new therapy and diagnostic features.
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