Change to the shelf-life expiration of polyurethane tubing from 36 months to ¿indefinite¿.
Device | ACUITY STEERABLE/SPIRAL |
Classification Name | Permanent Defibrillator Electrodes |
Generic Name | Permanent Defibrillator Electrodes |
Applicant | GUIDANT CORP. |
Date Received | 2010-08-23 |
Decision Date | 2010-09-22 |
PMA | P050046 |
Supplement | S007 |
Product Code | NVY |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | Yes |
Applicant Address | GUIDANT CORP. 4100 Hamline Avenue North st. Paul, MN 55112-5798 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P050046 | | Original Filing |
S032 |
2021-09-01 |
30-day Notice |
S031 |
2021-03-08 |
30-day Notice |
S030 |
2021-01-11 |
30-day Notice |
S029 |
2018-07-13 |
30-day Notice |
S028 |
2018-03-26 |
30-day Notice |
S027 | | |
S026 |
2015-06-22 |
30-day Notice |
S025 |
2015-06-05 |
30-day Notice |
S024 |
2014-07-25 |
30-day Notice |
S023 |
2014-01-28 |
Real-time Process |
S022 |
2013-11-18 |
30-day Notice |
S021 |
2013-08-29 |
30-day Notice |
S020 |
2013-08-19 |
30-day Notice |
S019 |
2012-11-14 |
Real-time Process |
S018 |
2012-11-08 |
30-day Notice |
S017 |
2012-10-02 |
30-day Notice |
S016 |
2012-09-04 |
30-day Notice |
S015 |
2012-07-30 |
30-day Notice |
S014 |
2012-03-26 |
30-day Notice |
S013 |
2012-01-24 |
30-day Notice |
S012 |
2011-12-02 |
Real-time Process |
S011 |
2011-05-25 |
30-day Notice |
S010 |
2011-04-01 |
30-day Notice |
S009 |
2011-01-26 |
135 Review Track For 30-day Notice |
S008 | | |
S007 |
2010-08-23 |
30-day Notice |
S006 |
2009-12-18 |
30-day Notice |
S005 |
2009-12-16 |
30-day Notice |
S004 |
2009-02-04 |
135 Review Track For 30-day Notice |
S003 |
2008-08-01 |
30-day Notice |
S002 |
2007-11-23 |
Real-time Process |
S001 | | |
NIH GUDID Devices