TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES
FDA premarket approval P960040/S337 · decided 2015-01-06
Approval details
- PMA number
- P960040
- Supplement
- S337
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN ICD DEVICES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-11-20
- Decision date
- 2015-01-06
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
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