REVO MRI SURESCAN IPG AND PACING SYSTEM
FDA premarket approval P090013 · decided 2011-02-08
Approval details
- PMA number
- P090013
- Trade name
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2009-06-09
- Decision date
- 2011-02-08
- Days to decision
- 609 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE REVO MRISURESCAN PACING SYSTEM, WHICH CONSISTS OF THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG, THE MEDTRONIC CAPSUREFIX MRI¿ SURESCAN¿ 5086MRI LEAD, AND THE REVO MRI¿ SOFTWARE APPLICATION MODEL SW018. THIS SYSTEM IS INDICATED AS FOLLOWS:THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A REVO MRI SURESCAN IPG IMPLANTED WITH TWO CAPSURE FIX MRI¿SURESCAN¿ 5086MRI LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THE MRI ENVIRONM
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