SIR-SPHERES

FDA Premarket Approval P990065 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing and sterilization site located in wilmington, massachusetts.

• Device: SIR-SPHERES
• Generic Name: Microspheres Radionuclide
• Applicant: Sirtex Medical Pty Ltd
• Date Received: 2006-05-15
• Decision Date: 2008-01-18
• PMA: P990065
• Supplement: S004
• Product Code: NAW
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Express Gmp Supplement
• Expedited Review: No
• Combination Product: No
• Applicant Address: Sirtex Medical Pty Ltd shop 6 207 Pacific Highway st Leonards, New South Wales 2065

Supplemental Filings

Supplement Number	Date	Supplement Type
P990065		Original Filing
S012	2022-03-21	30-day Notice
S011
S010	2016-12-19	Special (immediate Track)
S009	2016-08-08	Normal 180 Day Track No User Fee
S008	2015-01-15	30-day Notice
S007	2014-09-09	Special (immediate Track)
S006	2011-09-19	Normal 180 Day Track No User Fee
S005
S004	2006-05-15	Normal 180 Day Track No User Fee
S003
S002
S001	2003-03-25	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
M425SIRY0010	P990065	006
00850014612146	P990065	015