FRONTIER II DEVICE MODEL 5586
FDA premarket approval P030035/S010 · decided 2006-03-02
Approval details
- PMA number
- P030035
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRONTIER II DEVICE MODEL 5586
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-02-21
- Decision date
- 2006-03-02
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A NEW ANALOG CHIP FOR USE IN THE ST. JUDE MEDICAL FRONTIER II DEVICE MODEL 5586.
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