DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D
FDA premarket approval P010012/S399 · decided 2015-10-02
Approval details
- PMA number
- P010012
- Supplement
- S399
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2015-09-02
- Decision date
- 2015-10-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE NG3 AND NG2.5 HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |