EPIC HF CRT-D SYSTEM
FDA premarket approval P030054/S107 · decided 2008-11-14
Approval details
- PMA number
- P030054
- Supplement
- S107
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPIC HF CRT-D SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-10-22
- Decision date
- 2008-11-14
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MERLIN@HOME MODEL EX1100 TRANSMITTER WITH INDUCTIVE TELEMETRY.
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