FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S
FDA premarket approval P030035/S133 · decided 2015-08-27
Approval details
- PMA number
- P030035
- Supplement
- S133
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-02-11
- Decision date
- 2015-08-27
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
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