prodisc C Total Disc Replacement

FDA Premarket Approval P070001 S018

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 additional cleaning, passivation and thermal rinse steps, and the following four (4) manufacturing sites, at the following addresses, and for the following purposes:centinel spine (manufacturer)900 airport road suite 3bwest chester, pa 19380hammill medical (contract manufacturer)360 tomahawk drivemaumee, oh 43537fruh verpackungstechnik ag (contract manufacturer)allmendstrasse 47fehraltoff switzerland 8320synergy health daniken ag (contract sterilizer)hogenweidstrasse 6daniken solothurn switzerland 4658

Deviceprodisc C Total Disc Replacement
Generic NameProsthesis, Intervertebral Disc
ApplicantCentinel Spine, LLC
Date Received2019-06-21
Decision Date2020-05-08
PMAP070001
SupplementS018
Product CodeMJO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Centinel Spine, LLC 900 Airport Road, Suite 3b west Chester, PA 19380

Supplemental Filings

Supplement NumberDateSupplement Type
P070001Original Filing
S018 2019-06-21 Normal 180 Day Track No User Fee
S017 2018-12-04 Normal 180 Day Track No User Fee
S016 2017-09-20 30-day Notice
S015 2017-06-30 30-day Notice
S014
S013 2014-04-03 135 Review Track For 30-day Notice
S012 2012-03-13 135 Review Track For 30-day Notice
S011 2011-07-19 30-day Notice
S010 2011-07-18 135 Review Track For 30-day Notice
S009 2010-08-02 Real-time Process
S008 2010-06-07 30-day Notice
S007 2010-06-02 30-day Notice
S006 2010-05-27 30-day Notice
S005 2010-05-27 135 Review Track For 30-day Notice
S004 2010-05-19 Normal 180 Day Track No User Fee
S003
S002 2008-03-12 Normal 180 Day Track No User Fee
S001 2008-01-31 Real-time Process

NIH GUDID Devices

Device IDPMASupp
10705034763897 P070001 000
10705034763729 P070001 000
10705034763736 P070001 000
10705034763743 P070001 000
10705034763750 P070001 000
10705034763767 P070001 000
10705034763774 P070001 000
10705034763781 P070001 000
10705034763798 P070001 000
10705034763804 P070001 000
10705034763811 P070001 000
10705034763880 P070001 000
10705034763873 P070001 000
10705034763866 P070001 000
10705034763859 P070001 000
10705034763842 P070001 000
10705034763835 P070001 000
10705034763828 P070001 000
H98109820046S04 P070001 011
H98109820045S03 P070001 011
H98109820037S04 P070001 011
H98109820036S03 P070001 011
H98109820035S02 P070001 011
H98109820027S03 P070001 011
H98109820026S02 P070001 011
H98109820047S05 P070001 011
H98109820055S04 P070001 011
H98109820056S05 P070001 011
H98109820057S06 P070001 011
H98109820065S05 P070001 011
H98109820066S06 P070001 011
H98109820067S07 P070001 011
H98109820075S06 P070001 011
H98109820076S07 P070001 011
H98109820077S08 P070001 011
H98109820025S01 P070001 011

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