REVO MRI
FDA premarket approval P090013/S035 · decided 2011-08-19
Approval details
- PMA number
- P090013
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REVO MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2011-07-20
- Decision date
- 2011-08-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE THE BUTTED CONTACT (BTC) ETCH TIME.
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