Paddle Leads
FDA premarket approval P010032/S157 · decided 2021-02-22
Approval details
- PMA number
- P010032
- Supplement
- S157
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paddle Leads
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-11-27
- Decision date
- 2021-02-22
- Days to decision
- 453 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval to add Abbott Medical Puerto Rico facility located at Km 67.5 Rd2 Arecibo, Puerto Rico, 00612 as an alternate sterilization and manufacturing site of the Paddle Lead and Internal Lead Extension products.
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