ST. JUDE MEDICAL ADAPTER
FDA premarket approval P010032/S087 · decided 2015-02-12
Approval details
- PMA number
- P010032
- Supplement
- S087
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST. JUDE MEDICAL ADAPTER
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-11-18
- Decision date
- 2015-02-12
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR MINOR LABELING CHANGES TO THE SJM 8-CHANNEL ADAPTOR (MODELS 2311 AND 2316); SPECIFICALLY, TO INCLUDE THE USE OF THE ADAPTOR WITH THE SJM TRIAL SYSTEM.
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