Implantable Pulse Generators
FDA premarket approval P140009/S033 · decided 2018-01-12
Approval details
- PMA number
- P140009
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Pulse Generators
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-12-15
- Decision date
- 2018-01-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Change in the Process Challenge Devices (PCDs) that are used in St. Jude Medicals current sterilization process for products sterilized at Medline Industries (Medline).
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