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Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

Tue, 12/21/2010 - 9:36am
U.S. Food & Drug Administration

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report.

As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Links to all available summary review memos can be found in the table below.

Device NamePMA Number  
Evia/Entovis Pulse GeneratorsP070008/S017Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP070008/S011Review MemoApproval Order
Paradym CRT-D Model 8750P060027/S026Review MemoApproval Order
Paradym CRT-D Model 8750 with Hardware and Manufacturing Changes and Labeling and Programmer Software Changes to the Ovatio VR Model 6250, DR Model 6550 and CRT-D Model 6750P060027/S015Review MemoApproval Order
Juvederm Ultra XC and Juvederm Ultra Plus XCP050047/S005Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP050023/S033Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP050023/S024Review MemoApproval Order
Restylane L and Perlane L Injectable GelsP040024/S039Review MemoApproval Order
Merlin Patient Care System (PCS) programmer model 3650P030054/S146Review MemoApproval Order
Unify CRT-D Models CD3231-40 and CD3231-40QP030054/S141Review MemoApproval Order
Epic HF CRT-D SystemP030054/S131Review MemoApproval Order
QuickFlex μ Model 1258T Left Ventricular LeadP030054/S130Review MemoApproval Order
TELIGEN ICD Models E103, E111, E102, and E110; COGNIS CRT-D Models N120, N118, and N119P010012/S212Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP000009/S040Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP000009/S035Review MemoApproval Order
Floseal Hemostatic Matrix 5ml/10ml KitP990009/S025Review MemoApproval Order
Paradym DR model 8550 and Paradym VR model 8250P980049/S059Review MemoApproval Order
Paradym VR Model 8250 and DR Model 8550 with Smartview 2.18UG1 Programmer SoftwareP980049/S050Review MemoApproval Order
XC202 Ceramic Capacitor EnRhythm Model P1501DR; Adapta IPG (DR/SR/VDD) Models ADD01, ADDR01, ADDR03, ADDR06, ADDRL1; Versa DR IPG Model VEDR01; Sensia IPG (D/DR/S/SR) SED01, SEDRL1, SES01, SEDR01, SESR01; and Relia IPG (D/DR/S/SR/VDD) Models RED01, REDR01, RES01, RESR01, REVDD01P980035/S153Review MemoApproval Order
Linox Smart Steroid-Eluting Dual Coil ICD LeadsP980023/S038Review MemoApproval Order
TELIGEN ICD Models E103, E111, E102, and E110; COGNIS CRT-D Models N120, N118, and N119P960040/S198Review MemoApproval Order
OptiSense Model 1999 Right Atrial LeadP960013/S057Review MemoApproval Order
Tendril STS Model 1988TC LeadP960013/S054Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP950037/S083Review MemoApproval Order
Reliaty/Model 3145 Pacing System AnalyzerP950037/S079Review MemoApproval Order
Evia/Entovis Pulse GeneratorsP950037/S072Review MemoApproval Order
Endotak Reliance 4-Site Lead Models 0262, 0263, 0265, 0266

Endotak Reliance 4-Site Lead Models 0272, 0273, 0275, 0276

Endotak Reliance 4-Site Lead Models 0282, 0283, 0285, 0286

Endotak Reliance 4-Site Lead Models 0292, 0293, 0295, 0296

4-Site Terminal Tool Model 7001

Lead Cap Kit Model 7007

4-Site Lead Pulling Tip Model 7006

P910073/S077Review MemoApproval Order
Fortify VR/DR Models CD1231-40, CD1231-40Q, CD2231-40, and CD2231-40QP910023/S226Review MemoApproval Order
Cadence ICD SystemP910023/S215Review MemoApproval Order
Lead Tunneler Model 6888P830060/S062Review MemoApproval Order

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