SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD
FDA premarket approval P060027/S008 · decided 2009-02-04
Approval details
- PMA number
- P060027
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-11-12
- Decision date
- 2009-02-04
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.
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