EPIC HF SYSTEM
FDA premarket approval P030054/S033 · decided 2006-08-09
Approval details
- PMA number
- P030054
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPIC HF SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-07-13
- Decision date
- 2006-08-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE TO AN AUTOMATED SELECTIVE SOLDERING PROCESS AS AN ALTERNATE METHOD FOR THE SOLDERING ON THE PEPIN BOARD OF THE MODEL 3650 MERLIN PCS.
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