REVO MRI SURESCAN IPG
FDA premarket approval P090013/S190 · decided 2015-07-20
Approval details
- PMA number
- P090013
- Supplement
- S190
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REVO MRI SURESCAN IPG
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2015-06-24
- Decision date
- 2015-07-20
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW VENDOR FOR THE SOLDER PROCESS FOR HYBRID COMPONENTS; THE SOLDER PROCESS ITSELF IS ALSO BEING UPDATED TO REMOVE AND REPLACE EXPOSED TIN WITH STANDARD LEAD/TIN.
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