ANTHEM RFCRT-PS
FDA premarket approval P030035/S122 · decided 2014-07-09
Approval details
- PMA number
- P030035
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Trade name
- ANTHEM RFCRT-PS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-06-12
- Decision date
- 2014-07-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- MODIFY THE DEVICE POST STERILIZATION TEST (DPST) AT ATE FOR THE RF TELEMETRY OF THE DEVICES.
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