FDA.reportPublic FDA data

PowerCel™ 170 Mini

Primary DI
00197420015469
Brand
PowerCel™ 170 Mini
Company
Advanced Bionics, LLC
Model
CI-5527-150
Device description
velvet black
Published
2026-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P960058171

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058171CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197420015469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197420015469001974200154691974200154690197420015469

GMDN Terms#

Term, Definition table
TermDefinition
Secondary batteryA rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
803906382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197420015179PowerCel™ 110 MiniCI-5521-1202026-10-26
00197420015186PowerCel™ 110 MiniCI-5521-1302026-10-26
00197420015216PowerCel™ 110 MiniCI-5521-1402026-10-26
00197420015223PowerCel™ 110 MiniCI-5521-1502026-10-26
00197420015254PowerCel™ 110 MiniCI-5521-1602026-10-26
00197420015278PowerCel™ 110 MiniCI-5521-1702026-10-26
00197420015292PowerCel™ 170 MiniCI-5527-2302026-10-26
00197420015315PowerCel™ 170 MiniCI-5527-2402026-10-26
00197420015339PowerCel™ 110CI-5511-1202026-10-26
00197420015353PowerCel™ 110CI-5511-1302026-10-26
00197420015377PowerCel™ 110 MiniCI-5521-2402026-10-26
00197420015407PowerCel™ 170 MiniCI-5527-1202026-10-26
00197420015421PowerCel™ 170 MiniCI-5527-1302026-10-26
00197420015445PowerCel™ 170 MiniCI-5527-1402026-10-26
00197420015483PowerCel™ 110CI-5511-1402026-10-26
00197420015506PowerCel™ 110CI-5511-1502026-10-26
00197420015520PowerCel™ 110CI-5511-1602026-10-26
00197420015544PowerCel™ 110CI-5511-1702026-10-26
00197420015568PowerCel™ 110CI-5511-1902026-10-26
00197420015582PowerCel™ 110CI-5511-1102026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197420015179PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015186PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015216PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015223PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015254PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015278PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015292PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015315PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015339PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015353PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015377PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015407PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015421PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015445PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015483PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015506PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015520PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015544PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015568PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015582PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015827PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015858PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015872PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015896PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015964PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015995PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016008PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016022PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016046PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016244PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26