MICRONY FAMILY OF PACEMAKERS
FDA premarket approval P970013/S042 · decided 2011-09-08
Approval details
- PMA number
- P970013
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MICRONY FAMILY OF PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-08-08
- Decision date
- 2011-09-08
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODEL 3330 VERSION 13.1 PROGRAMMER SOFTWARE WHICH INCLUDES ENHANCEMENTS TO THE LAYOUT/DESIGN OF THE EXISTING MERLIN PCS PRINTED REPORTS.
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