PMA P910077S018
- Device
- VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S018
- Product code
- LWS
- Decision date
- 1997-05-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR RHYTHMLINE(TM) TRANSTELEPHONIC INTERROGATION SYSTEM WHICH WILL PROVIDE REMOTE INTERROGATION AND DATA RETRIEVAL AND ECG MONITORING OF PATIENTS WITH VENTAK PRX II AND PRX III PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S018
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1997-05-06
- Decision code
- APPR
- Date received
- 1996-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR RHYTHMLINE(TM) TRANSTELEPHONIC INTERROGATION SYSTEM WHICH WILL PROVIDE REMOTE INTERROGATION AND DATA RETRIEVAL AND ECG MONITORING OF PATIENTS WITH VENTAK PRX II AND PRX III PULSE GENERATORS.