OCTRODE LEADS
FDA premarket approval P010032/S080 · decided 2014-06-27
Approval details
- PMA number
- P010032
- Supplement
- S080
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OCTRODE LEADS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-05-29
- Decision date
- 2014-06-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- IMPLEMENT CHANGES TO THE TESTING AND INSPECTION PROCESS.
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