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AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set

FDA premarket approval P980037/S090 · decided 2023-08-08

Approval details

PMA number
P980037
Supplement
S090
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set
Generic name
CATHETER, CORONARY, ATHERECTOMY
Applicant
Boston Scientific Corp
Date received
2023-06-29
Decision date
2023-08-08
Days to decision
40 days
Decision code
APPR
Product code
MCX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for an additional manufacturing site located in Dorado, PR for the Sprioflex and Spiroflex VG Thrombectomy Sets manufacturing, sterile packaging, and post production quality assurance.

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