ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD
FDA premarket approval P960040/S360 · decided 2015-12-21
Approval details
- PMA number
- P960040
- Supplement
- S360
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORIGEN, INOGEN, AND DYNAGEN ICD, INCEPTA, ENERGEN, AND PUNCTUA ICD, TELIGEN ICD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-11-09
- Decision date
- 2015-12-21
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR HARDWARE MODIFICATIONS TO THE NG3 FAMILY OF DEVICES.
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