ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT
FDA premarket approval P970024/S003 · decided 1999-09-14
Approval details
- PMA number
- P970024
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ANGEION SENTINEL(TM) IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(ICD)SYSTEM: REMOVAL OF PATIENT MONITORING REQUIREMENT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1999-07-01
- Decision date
- 1999-09-14
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.