EPIC HF CRT-DS
FDA premarket approval P030054/S062 · decided 2007-08-17
Approval details
- PMA number
- P030054
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Trade name
- EPIC HF CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-07-19
- Decision date
- 2007-08-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE SUPPLIER FOR THE PARYLENE DIMER USED IN THE PARYLENE COATING FOR THE DEVICE.
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