RITHRON-XR CORONARY STENT SYSTEM
FDA premarket approval P030037 · decided 2005-04-29
Approval details
- PMA number
- P030037
- Trade name
- RITHRON-XR CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Biotronik GmbH & Co. KG
- Date received
- 2003-09-02
- Decision date
- 2005-04-29
- Days to decision
- 605 days
- Decision code
- APWD
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berlin
- Statement
- APPROVAL FOR THE RITHRON-XR CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR USE IN PATIENTS ELIGIBLE FOR BALLOON ANGIOPLASTY WITH SYMPTOMATIC ISCHEMIC HEART DISEASE CHARACTERIZED BY DISCRETE DE NOVO CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETER FROM >=3.0 MM OR <=4.0 MM AND TARGET LESION LENGTH <=20.0 MM.
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