ANTENNA AND PORTABLE CHARGER
FDA premarket approval P010032/S054 · decided 2012-07-12
Approval details
- PMA number
- P010032
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANTENNA AND PORTABLE CHARGER
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-06-01
- Decision date
- 2012-07-12
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL TO REVERSE THE GENDER OF THE CONTACTS OF THE PLUG AND RECEPTACLE ON THE PORTABLE CHARGER (MODELS 3711 AND 3715) I.E., A RECEPTACLE FOR CONNECTING THE CHARGING ANTENNA WILL NOW HAVE FEMALE PINS FOR CONTACTS, WHILE THE MATING PLUG ON THE CHARGING ANTENNA WILL NOW HAVE MALE CONTACTS. ADDITIONALLY, IT WAS REQUESTED TO CHANGE THE PIN-OUT CONNECTOR FROM A 3 PIN VERSION TO A 4 PIN VERSION.
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