Who is the manufacturer of SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH?

Spectranetics (Philips) filed the PMA application for SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH (P960042).

What is the FDA product code for SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH?

MFA. as a Class 3 device in the Cardiovascular panel.

Who can help prepare an FDA PMA submission like SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA PMA submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH

P960042 · Spectranetics (Philips) · MFA · Dec 9, 1997 · Cardiovascular

Device Facts

Record ID	P960042
Device Name	SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
Applicant	Spectranetics (Philips)
Product Code	MFA · Cardiovascular
Decision Date	Dec 9, 1997
Decision	APPR
Device Class	Class 3
Attributes	Expedited Review

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