Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT
FDA premarket approval P010012/S504 · decided 2019-07-31
Approval details
- PMA number
- P010012
- Supplement
- S504
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Boston Scientific Corp
- Date received
- 2019-05-03
- Decision date
- 2019-07-31
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for enhancements and modifications to existing market released products including hardware, MRI labeling and manufacturing changes as well as software updates.
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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 |