CapSureFix MRI Lead
FDA premarket approval P090013/S295 · decided 2018-12-17
Approval details
- PMA number
- P090013
- Supplement
- S295
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSureFix MRI Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2018-11-21
- Decision date
- 2018-12-17
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Transfer an intermediate manufacturing step to fill Dexamethasone Sodium Phosphate and Dexamethasone Acetate into vials from Medtronic Energy and Component Center to the Medtronic Cardiac Rhythm Heart Failure Rice Creek Pharma Manufacturing Operations facility and to implement minor process improvements.
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