PMA P880065S007
- Device
- AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S007
- Product code
- LOT
- Decision date
- 2002-06-25
- Classification
- Cardiovascular
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Approval order statement
- ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
Current openFDA PMA Record#
- Device
- AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S007
- Product code
- LOT
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Decision date
- 2002-06-25
- Decision code
- OK30
- Date received
- 2002-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.