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ZOLL Manufacturing Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086426523008642652ZOLL Manufacturing Corporation1N2026-01-01121 Gamma Dr Pittsburgh PA US 15238

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1243271696968463P010030WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVESTMVK2001-12-18
1243271310271124K190939ZOLL Arrhythmia Management SysyemMHX2019-12-19
1243271296845541K182093ZOLL ECG Analysis SoftwareDPS2019-01-28
1243271687251790K172510µCor Heart Failure and Arrhythmia Management SystemMHX2018-05-11
1243271945093964K102507AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTORDSI2011-06-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX22019-12-19
DPS12019-01-28
DSI12011-06-13
MVK12001-12-18

PMA#

LifeVest® Wearable Defibrillator

2023-01-19

ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS163 Date Received01/09/2023 Decision Date01/19/2023 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

LifeVest® Wearable Defibrillator

2022-08-18

ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS160 Date Received08/03/2022 Decision Date08/18/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

LifeVest Wearable Defibrillator

2022-06-01

ZOLL MANUFACTURING CORPORATION121 Gamma Drpittsburgh, PA 15238-0000 PMA NumberP010030 Supplement NumberS159 Date Received05/17/2022 Decision Date06/01/2022 Product Code MVK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pr...

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PMN#

GUDID#