EPIC HF CRT-D SYSTEM
FDA premarket approval P030054/S093 · decided 2008-07-09
Approval details
- PMA number
- P030054
- Supplement
- S093
- 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
- 2008-05-30
- Decision date
- 2008-07-09
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE MERLIN@HOME TRANSMITTER MODEL EX1200, WHICH REPLACE THE LCD TOUCH SCREEN WITH A MEMBRANE PANEL AND CONSOLIDATE INTERNAL CIRCUITRY. THE DEVICE, AS MODIFIED, WILL BE MARKETED AS MODEL EX1150.
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