S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
FDA premarket approval P000022/S008 · decided 2001-10-02
Approval details
- PMA number
- P000022
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic Vascular
- Date received
- 2001-09-07
- Decision date
- 2001-10-02
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE.
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