MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER
FDA premarket approval P970013/S025 · decided 2008-06-27
Approval details
- PMA number
- P970013
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-06-02
- Decision date
- 2008-06-27
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
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