FDA.reportPublic FDA data

Peter Nowakowski

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30275453773027545377Peter Nowakowski1N2026-01-015403 Betsy Ross Dr Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3327901023402901P200039Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) CatheterQMG2021-02-12
3327901257805239K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterPPN2024-03-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PPN12024-03-22
QMG 12021-02-12