ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
FDA premarket approval P030054/S146 · decided 2010-05-03
Approval details
- PMA number
- P030054
- Supplement
- S146
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-02-05
- Decision date
- 2010-05-03
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR: 1) THE ADDITION OF THE PACING SYSTEMS ANALYZER (PSA) MODEL EX3100. THE MODEL EX3100 ALSO INCLUDES ACCESSORIES: A) MERLIN ANTENNA ADAPTER EX3190; B) MERLIN CABLE ADAPTER EX3170; AND C) MERLIN ¿M¿ ADAPTER EX3180; AND 2) THE ADDITION OF THE MODEL 3330 VERSION 10.1.1 SOFTWARE.
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