PMA P010032S054
- Device
- ANTENNA AND PORTABLE CHARGER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S054
- Product code
- LGW
- Decision date
- 2012-07-12
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order 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.
Current openFDA PMA Record#
- Device
- ANTENNA AND PORTABLE CHARGER
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S054
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2012-07-12
- Decision code
- APPR
- Date received
- 2012-06-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.