EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI
FDA premarket approval P010032/S111 · decided 2016-02-17
Approval details
- PMA number
- P010032
- Supplement
- S111
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-01-19
- Decision date
- 2016-02-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Use of alternative batch sampling methods for bacterial endotoxin testing (BET) at the SJM Arecibo, Puerto Rico facility.
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