EXTERNAL PULSE GENERATOR, 2 PORT HEADER
FDA premarket approval P010032/S103 · decided 2015-11-05
Approval details
- PMA number
- P010032
- Supplement
- S103
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXTERNAL PULSE GENERATOR, 2 PORT HEADER
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-10-06
- Decision date
- 2015-11-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- IMPLEMENTATION OF UPDATES TO THE TEST EQUIPMENT AND MEASUREMENT TECHNIQUES USED DURING THE MANUFACTURING PROCESS OF THE MICRO HDMI CONNECTOR OF THE SJM EPG HEADER MODEL 3032.
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