EPIC HF CRT-D SYSTEM
FDA premarket approval P030054/S133 · decided 2009-11-13
Approval details
- PMA number
- P030054
- Supplement
- S133
- 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
- 2009-09-01
- Decision date
- 2009-11-13
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER AND ASSOCIATED DESIGN CHANGES FOR THE ANTENNA PRINTED CIRCUIT BOARD (PCB) FOR THE MERLIN@HOME MODEL EX1150 TRANSMITTER.
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