TELIGEN, PROGENY ICD AND NG ICD MODELS
FDA premarket approval P960040/S316 · decided 2014-07-16
Approval details
- PMA number
- P960040
- Supplement
- S316
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELIGEN, PROGENY ICD AND NG ICD MODELS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-05-09
- Decision date
- 2014-07-16
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.
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