Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr
FDA premarket approval P010032/S117 · decided 2016-05-27
Approval details
- PMA number
- P010032
- Supplement
- S117
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-04-28
- Decision date
- 2016-05-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Addition of an alternate supplier of inner tubing and addition of isopropyl alcohol to aid in the assembly of SCS and DBS leads.
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