PMA P910077S136
- Device
- ZOOM LATITUDE PROGRAMMER
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S136
- Product code
- LWS
- Decision date
- 2013-08-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ALTERNATE SUPPLIER FOR THE OFF-THE-SHELF FLASH MEMORY CHIP TO BE USED ON THEINPUT/OUTPUT (I/O) PRINTED CIRCUIT ASSEMBLY (PCA) OF THE DEVICE.
Current openFDA PMA Record#
- Device
- ZOOM LATITUDE PROGRAMMER
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S136
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-08-21
- Decision code
- OK30
- Date received
- 2013-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR THE OFF-THE-SHELF FLASH MEMORY CHIP TO BE USED ON THEINPUT/OUTPUT (I/O) PRINTED CIRCUIT ASSEMBLY (PCA) OF THE DEVICE.