PMA P910077S175
- Device
- LATITUDE Programming System
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S175
- Product code
- LWS
- Decision date
- 2019-11-26
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a new functional tester to the Model 3300 LATITUDE Programming Sytem manufacturing line.
Current openFDA PMA Record#
- Device
- LATITUDE Programming System
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S175
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-11-26
- Decision code
- OK30
- Date received
- 2019-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new functional tester to the Model 3300 LATITUDE Programming Sytem manufacturing line.