RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr
FDA premarket approval P930029/S059 · decided 2018-03-16
Approval details
- PMA number
- P930029
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RF Marinr, Unipolar Mapping RF Marinr, RF Conductr MC, RF Enhancr, and RF Contactr
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 2018-02-22
- Decision date
- 2018-03-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Device History Record (DHR) review optimization at Medtronic Puerto Rico Operations Company (MPROC) in Villalba, Puerto Rico
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