PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
FDA premarket approval P880027/S062 · decided 2002-06-25
Approval details
- PMA number
- P880027
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 2002-05-29
- Decision date
- 2002-06-25
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
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