PMA P820022S003
- Device
- CYBERTACH
- Applicant
- Boston Scientific
- PMA number
- P820022
- Supplement
- S003
- Product code
- LWW
- Decision date
- 2004-11-19
- Classification
- Cardiovascular
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Approval order statement
- CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.
Current openFDA PMA Record#
- Device
- CYBERTACH
- Applicant
- Boston Scientific
- PMA number
- P820022
- Supplement
- S003
- Product code
- LWW
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Decision date
- 2004-11-19
- Decision code
- OK30
- Date received
- 2004-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PROCEDURES FOR INSPECTIONS OF MATERIALS/ COMPONENTS RECEIVED FROM SUPPLIERS.