VENTAK PRX AND VENTAK MINI SYSTEMS
FDA premarket approval P910077/S144 · decided 2014-08-12
Approval details
- PMA number
- P910077
- Supplement
- S144
- Supplement type
- Real-Time Process
- Trade name
- VENTAK PRX AND VENTAK MINI SYSTEMS
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Boston Scientific
- Date received
- 2014-06-09
- Decision date
- 2014-08-12
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 2909 MULTIPLE APPLICATION UTILITY SYSTEM SOFTWARE V9.03 AND MODEL 2905 PDF REPORT GENERATION SOFTWARE V1.02 WHICH RESIDE ON THE ZOOM LATITUDE PROGRAMMING SYSTEM MODEL 3120.
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