PADDLE LEAD KITS DFU
FDA premarket approval P010032/S035 · decided 2010-11-17
Approval details
- PMA number
- P010032
- Supplement
- S035
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PADDLE LEAD KITS DFU
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-10-21
- Decision date
- 2010-11-17
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR LABELING CHANGES THAT CLARIFY THE SURGICAL PROCEDURES USED TO IMPLANT PADDLE LEADS.
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