EPIC HF CRT-D SYSTEM
FDA premarket approval P030054/S111 · decided 2008-12-19
Approval details
- PMA number
- P030054
- Supplement
- S111
- 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
- 2008-11-28
- Decision date
- 2008-12-19
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE VERSION 3.1 OF THE MODEL EX2000 SOFTWARE FOR THE MERLIN@HOME DEVICES.
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