TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4
FDA premarket approval P010032/S084 · decided 2014-10-06
Approval details
- PMA number
- P010032
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-09-08
- Decision date
- 2014-10-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- ADD MANUFACTURING PROCESS CHANGES TO THE CUTTINGMETHODS, AND CHANGE IN THE FREQUENCY OF LUBRICANT DISPENSING.
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