Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P
FDA premarket approval P010015/S336 · decided 2017-07-18
Approval details
- PMA number
- P010015
- Supplement
- S336
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Consulta, Percept Bipolar, Percepta Quadripolar, Serena Bipolar/Quadripolar, Syncra, Viva CRT-P
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2017-06-23
- Decision date
- 2017-07-18
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.3 at Medtronic Swiss Manufacturing Operations.
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