PMA P920051

Device: STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S007
Product code: LNS
Decision date: 1997-10-31
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).

Current openFDA PMA Record#

Device: STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S007
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1997-10-31
Decision code: APRL
Date received: 1997-10-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).