Atlas FDA

Precision Passing Elevator

FDA premarket approval P030017/S351 · decided 2023-06-06

Approval details

PMA number
P030017
Supplement
S351
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Passing Elevator
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2022-08-22
Decision date
2023-06-06
Days to decision
288 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Approval for the addition of an alternate supplier (AUSA Medical Devices Private Limited) for the passing elevator component used with the Precision Spinal Cord Stimulator (SCS) Systems, as well as changes to the manufacturing process (addition of a tumbling process and cleaning step with 70% IPA) and resin material

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