PMA P970024S003

Device: ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT
Applicant: MicroPort CRM USA, Inc.
PMA number: P970024
Supplement: S003
Product code: LWS
Decision date: 1999-09-14
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement.

Current openFDA PMA Record

Device: ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT
Applicant: MicroPort CRM USA, Inc.
PMA number: P970024
Supplement: S003
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 1999-09-14
Decision code: APPR
Date received: 1999-07-01
Supplement type: Normal 180 Day Track
Supplement reason: Express GMP Supplement
Approval order statement: Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement.