FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS
FDA premarket approval P030035/S012 · decided 2006-04-28
Approval details
- PMA number
- P030035
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-03-30
- Decision date
- 2006-04-28
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.
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