Assurity MRI and Endurity MRI
FDA premarket approval P140033/S024 · decided 2018-02-01
Approval details
- PMA number
- P140033
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Assurity MRI and Endurity MRI
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-01-29
- Decision date
- 2018-02-01
- Days to decision
- 3 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Relocation of supplier manufacturing of certain battery components and use of an alternate component welding machine.
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