PERCUTANEOUS CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S209 · decided 2001-08-22
Approval details
- PMA number
- P810046
- Supplement
- S209
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCUTANEOUS CORONARY DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2001-05-17
- Decision date
- 2001-08-22
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MODIFICATIONS IN THE INSTRUCTIONS FOR USE BOOKLETS OF THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), ACS OTW PHOTON(TM), ACS RX GEMINI(TM), AND ACS RX ESPRIT PTCA CATHETERS.
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