MERLIN HOME 6.1M
FDA premarket approval P910023/S307 · decided 2012-12-19
Approval details
- PMA number
- P910023
- Supplement
- S307
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MERLIN HOME 6.1M
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-10-15
- Decision date
- 2012-12-19
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE EX2000 SOFTWARE VERSION 6.1 M FOR MARLIN@HOME WITHOUT THE CELLULAR ADAPTER AND SOFTWARE VERSION 6.0 FOR MERLIN.NET SYSTEM.
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