PMA P900056S218

Device: Rotawire Guidewire, ROTAWIRE Drive Guidewire
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S218
Product code: MCX
Decision date: 2025-01-17
Classification: Cardiovascular
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: the ROTAWIRE Drive and Rotawire distal spring component manufacturing line transfer from Heraeus Medical Components (HMC) in White Bear Lake, MN to their manufacturing facility in Singapore.

Current openFDA PMA Record#

Device: Rotawire Guidewire, ROTAWIRE Drive Guidewire
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S218
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 2025-01-17
Decision code: APPR
Date received: 2024-07-09
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the ROTAWIRE Drive and Rotawire distal spring component manufacturing line transfer from Heraeus Medical Components (HMC) in White Bear Lake, MN to their manufacturing facility in Singapore.