IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's
FDA premarket approval P960040/S383 · decided 2016-12-22
Approval details
- PMA number
- P960040
- Supplement
- S383
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-10-21
- Decision date
- 2016-12-22
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for changes to the high voltage capacitor in the NG2.5 family of ICDs.
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