RX5000(TM) PROGRAMMER
FDA premarket approval P830026/S066 · decided 1996-03-22
Approval details
- PMA number
- P830026
- Supplement
- S066
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RX5000(TM) PROGRAMMER
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-02-01
- Decision date
- 1996-03-22
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY, THE FOLLOWING MODELS ARE AFFECTED:COSMOS II 284-05/283-03 -- NOVA II 282-04/281-05/281-05S/282-04R/282-04Y -- QUANTUM II 254-30/253-25 -- NOVA III 282-09/282-09R/282-07/281/07 -- QUANTUM III 254-27 -- SUPRIMA III 254-31
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