CapSure Fix MRI Lead
FDA premarket approval P090013/S271 · decided 2018-04-03
Approval details
- PMA number
- P090013
- Supplement
- S271
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSure Fix MRI Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2018-03-06
- Decision date
- 2018-04-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of new dry chamber time and temperature settings, elimination of a wash and air dry operations, an update to inspection methods, and standardization of process operations description.
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