FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS
FDA premarket approval P030035/S083 · decided 2011-08-03
Approval details
- PMA number
- P030035
- Supplement
- S083
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PS
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-05-02
- Decision date
- 2011-08-03
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.
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