Atlas FDA

RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR

FDA 510(k) clearance K032561 · decided 2003-09-11

Clearance details

K-number
K032561
Device name
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2003-08-20
Decision date
2003-09-11
Days to decision
22 days
Clearance type
Special
Product code
GZB
Device class
2
Regulation number
882.5880
Medical specialty
Neurology
Advisory committee
Neurology
Location
Miinneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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