• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
Applicant
MEDTRONIC Inc.
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP980035
Supplement NumberS002
Date Received03/10/1999
Decision Date08/09/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Sigma family of pulse generators & software. The DR & SR series are indicated for rate adaptive pacing in pts who may benefit fr increased pacing rates concurrent w/increases in activity. The DR & D Series, SR & S Series, & VVI series are indicated for accepted pt conditions warranting chronic cardiac pacing which include:Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal or transient sinus node dysfunctions w/or w/o associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.The DR & D series pacemakers are also indicated for dual chamber & atrial tracking modes in pts whomay benefit fr maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include:Various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. The pulse generator, Medtronic.Sigma(TM) Model SVDD303 Pulse Generator is indicated for the following: accepted patient conditions warranting chronic cardiac pacing which includes: Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundel branch block. These pacemakers are also indicated for dual chamber & atrial tracking modes in pts who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate & AV synchrony, which include: various degrees of AV block to maintain the atrial contribution to cardiac output; VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm. The VDD Series pacemakers are also indicated for VDD modes in pts having adequae atrial rates & various indications.
-
-