Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
FDA premarket approval P060027/S101 · decided 2020-06-24
Approval details
- PMA number
- P060027
- Supplement
- S101
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2019-12-23
- Decision date
- 2020-06-24
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for alternate hardware components and electronic configurations used on the electronic assembly, the V2.4.6 software update, and labeling updates.
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