MICRONY FAMILY OF PACEMAKERS
FDA premarket approval P970013/S028 · decided 2009-01-15
Approval details
- PMA number
- P970013
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MICRONY FAMILY OF PACEMAKERS
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-12-31
- Decision date
- 2009-01-15
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL OF THE MODEL 3330 VERSION 7.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
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