MICRONY PACEMAKERS
FDA premarket approval P970013/S007 · decided 2006-04-05
Approval details
- PMA number
- P970013
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MICRONY PACEMAKERS
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-03-07
- Decision date
- 2006-04-05
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODEL 3330 VERSION 3.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM WHICH ADDS THE SUPPORT FOR THE USE OF MERLIN WITH THE VICTORY, EPIC II AND FRONTIER II PULSE GENERATOR FAMILIES.
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