PARADYM RF VR ICDS
FDA premarket approval P980049/S071 · decided 2013-05-09
Approval details
- PMA number
- P980049
- Supplement
- S071
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM RF VR ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-03-13
- Decision date
- 2013-05-09
- Days to decision
- 422 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE SMARTVIEW HOME MONITOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTVIEW HOME MONITOR AND IS INDICATED FOR USE WITH SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY AND ANY HOUSEHOLD TRADITIONAL (ANALOG TYPE) TELEPHONE LAND LINE; IT WILL NOT OPERATE WITH OTHER LINES SUCH AS AND NOT LIMITED TO DIGITAL, DSL OR OPTICAL FOR THE PSTN DEVICE AND THE SMARTVIEW MONITOR IS DESIGNED FOR USE WITH THE SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY FOR GPRS DE
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